DHS®/DCS® LAG SCREW 12.7MM THREAD/85MM-STERILE

Report

Report Number: 3003506883-2015-10018
Event Type: Injury
Date Received: January 13, 2015
Date of Event: December 21, 2014
Report Date: December 21, 2014
Manufacturer: SYNTHES ELMIRA
Product Code: KTT
PMA / PMN Number: PK791619
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative · 1

ADDITIONAL NARRATIVE: A PRODUCT INVESTIGATION WAS COMPLETED: ONE 135 DEGREE DHS PLATE, PART NUMBER 381.102S, AND ONE DHS/DCS GUIDE SHAFT, PART NUMBER 338.21 WAS RECEIVED, ONE DHS/DCS LAG SCREW, PART NUMBER 380.850S, WAS RECEIVED AND ONE DHS/DCS COUPLING SCREW, PART NUMBER 338.20, WAS RECEIVED. THE RETURNED DHS PLATE, LOT NUMBER 7802989, WAS MANUFACTURED OCT, 2014. IT WAS RECEIVED WITH A DENT DIRECTLY BELOW THE LAG SCREW HOLE ON THE LATERAL SURFACE OF THE PLATE. THE FLATS ON THE LAG SCREW BARREL, WHICH MATE WITH THE LAG SCREW, SHOW SLIGHT DEFORMATION. THE RETURNED DHS/DCS COUPLING SCREW, LOT NUMBER 1049, WAS MANUFACTURED MARCH, 1993. IT WAS RECEIVED IN GOOD CONDITION SHOWING ONLY WORN EDGES. THE RETURNED DHS/DCS GUIDE SHAFT, LOT NUMBER 1012, WAS MANUFACTURED JUNE, 1989. IT WAS RECEIVED WITH NICKS AND SCRATCHES OVER THE SURFACE OF THE DEVICE. THE PRONGS THAT COUPLE WITH THE LAG SCREW SHOW FLATTENING AND NICKS. THE BALANCE OF EACH RETURNED PART IS IN GOOD CONDITION. WHEN ASSEMBLED THE PLATE WILL NOT SLIDE OVER THE POINT WHERE THE GUIDE SHAFT CONNECTS TO THE LAG SCREW. THUS, THE COMPLAINT CONDITION IS CONFIRMED AND COULD BE REPLICATED. A REVIEW OF THE DESIGN DRAWINGS FOR THE PLATE, THE LAG SCREW, THE COUPLING SCREW, AND THE GUIDE SHAFT WAS PERFORMED. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED AND THE DESIGN WAS FOUND TO BE SUFFICIENT FOR ITS INTENDED USE. THEREFORE, THE COMPLAINT CONDITION WAS DETERMINED TO NOT BE THE RESULT OF A DESIGN DEFICIENCY. PER THE TECHNIQUE GUIDE, THE RETURNED IMPLANTS ARE PART OF THE DYNAMIC HIP SCREW (DHS) SYSTEM AND THE DEVICES ARE USED SPECIFICALLY FOR INSERTION OF THE LAG SCREW FOR A DHS OR A DYNAMIC CONDYLAR SCREW (DCS). ALTHOUGH THE ROOT CAUSE CANNOT BE DEFINITIVELY DETERMINED WITHOUT ADDITIONAL INFORMATION REGARDING THE USER TECHNIQUE AND THE CONDITIONS AT THE TIME OF THE DAMAGE, THE RETURNED CONDITION IS CONSISTENT WITH EXCESSIVE FORCE PRIOR TO ACHIEVING PROPER ALIGNMENT AND/OR THE EXTENSIVE WEAR OF THE DEVICES OVER AN EXTENDED LIFETIME. THE GUIDE SHAFT IS OVER 25 YEARS OLD AND THE COUPLING SCREW IS OVER 22 YEARS OLD. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative · 1

ADDITIONAL NARRATIVE: A MANUFACTURING INVESTIGATION ACTION WAS CONDUCTED/PERFORMED. THE REPORT INDICATES THAT: THE AS RECEIVED CONDITION OF THE IMPLANT WAS WHOLE AND IN GOOD CONDITION EXCEPT FOR DAMAGE AT THE SLOT AREA. EDGES OF SLOT WERE PEENED OVER AND HAD "TEETH" MARKS ALONG INNER EDGE OF SLOT. FEATURES AT THE LOCATION OF THE SLOT WERE UNOBTAINABLE. ALL OTHER RELEVANT DIMENSIONAL FEATURES WERE MEASURED AND PASSED PER THE CORRESPONDING PROCESS DOCUMENTATION. THE PARTS WERE EVALUATED WITH THE CURRENT GAGE TO THE CURRENT INSPECTION REQUIREMENTS AND WERE FOUND TO BE CONFORMING. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative · 1

LOT 7693376 EXPIRES IN MAY 2023. DEVICE WAS NOT IMPLANTED/EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED TO THE MANUFACTURER FOR REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY REVIEW: MANUFACTURED DATE: JUNE 10, 2014 - EXPIRY DATE: MAY 2023. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) REVEALED NO COMPLAINT RELATED ANOMALIES. THE DHR SHOWS LOT 7693376 OF DHS/DCS LAG SCREW WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NON-CONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT (7418196) MET ALL SPECIFICATIONS WITH NO ANOMALIES NOTED. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem · 1

IT WAS REPORTED THAT, DURING A DYNAMIC HIP SCREW (DHS) PROCEDURE ON A NON-DISPLACED INTERTROCHANTERIC FRACTURE, THE DEVICES WOULD NOT ALIGN PROPERLY. THE CONNECTING SCREW WOULD NOT KEY IN AS THE SURGEON PLACED THE LAG SCREW INTO THE FEMORAL HEAD AND SLID THE PLATE OVER THE CONNECTING SCREW. THE SURGEON USED AN IMPACTOR AND A MALLET IN AN ATTEMPT TO SEAT THE SCREW ONTO THE PLATE. THE LAG SCREW LOST FIXATION AT THE FEMORAL HEAD. AN X-RAY DETERMINED THAT THE LAG SCREW HAD MOVED AND THAT 6 INCHES OF BONE WAS LOST. AS SUCH, THE DHS WAS ABANDONED AND THE SURGERY WAS CONVERTED TO A TROCHANTERIC FIXATION NAIL PROCEDURE. THE SURGERY, DELAYED BY 30 MINUTES, WAS SUCCESSFULLY COMPLETED. THIS REPORT IS 2 OF 4 FOR (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
28585	DHS®/DCS® LAG SCREW 12.7MM THREAD/85MM-STERILE	APPLIANCE, FIXATION, NAIL	KTT	SYNTHES ELMIRA		7693376

Patients

Seq	Age	Sex	Outcome	Treatment
1	52 YR		Required Intervention