ZIMMER SKIN GRAFT MESHER

Report

Report Number: 0001526350-2016-00104
Event Type: Injury
Date Received: October 6, 2016
Date of Event: September 21, 2016
Report Date: July 13, 2017
Manufacturer: ZIMMER SURGICAL, INC.
Product Code: FZW
PMA / PMN Number: PEXEMPT
Removal / Correction Number: N/A
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: HOSPITAL SERVICE TECHNICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS RETURNED TO THE MANUFACTURER; HOWEVER, THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. INITIAL QA INSPECTION OF THE SKIN GRAFT MESHER ON (B)(6) 2016 REVEALED MINOR COSMETIC DAMAGE TO THE MESHER HANDLE INCLUDING NICKS AND SCRATCHES. THE LATCHING PINS ENGAGE AS INTENDED. THE COMB WAS BENT ON THE RIGHT HAND SIDE. THERE WAS MINOR WEAR NOTED TO THE ROLLER GEAR. THE TEST MESH USING THE CUSTOMER¿S MESHER AND RATCHET WAS UNABLE TO BE PERFORMED DUE TO THE BENT COMB. THE RATCHET APPEARED TO RATCHET NORMALLY. THE 1.5:1 RATIO CUTTER, SERIAL NUMBER (B)(4), HAD MINOR WEAR NOTED TO THE ROLLER GEAR AND CUTTER BLADES. THE 2:1 RATIO CUTTER, SERIAL NUMBER (B)(4), HAD MINOR WEAR NOTED TO THE ROLLER GEAR AND CUTTER BLADES. THE INSTRUMENT BROKE THE GRAFT AND THE REPORTED ISSUE OCCURRED DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT OR PATIENT HARM/INJURY ASSOCIATED WITH THE REPORT. AN ALTERNATE DEVICE WAS RETRIEVED FOR USE DURING THE SURGERY WITHOUT DELAY. THERE WAS AN IMPACT/DAMAGE TO GRAFT HARVEST AND NO ADDITIONAL UNPLANNED GRAFT HARVEST WAS REQUIRED FROM THE PATIENT, AS THEY USED ANOTHER METHOD TO USE THE SAME GRAFT.

Additional Manufacturer Narrative · 1

THIS REPORT IS BEING AMENDED TO REFLECT CHANGES. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE AND A ROOT CAUSE HAS BEEN ESTABLISHED.

Additional Manufacturer Narrative · 1

INITIAL QA INSPECTION OF THE SKIN GRAFT MESHER ON SEPTEMBER 21, 2016 REVEALED MINOR COSMETIC DAMAGE TO THE MESHER HANDLE INCLUDING NICKS AND SCRATCHES. THE LATCHING PINS ENGAGE AS INTENDED. THE COMB WAS BENT ON THE RIGHT HAND SIDE. THERE WAS MINOR WEAR NOTED TO THE ROLLER GEAR. THE TEST MESH USING THE CUSTOMER¿S MESHER AND RATCHET WAS UNABLE TO BE PERFORMED DUE TO THE BENT COMB. THE RATCHET APPEARED TO RATCHET NORMALLY. THE 1.5:1 RATIO CUTTER, SERIAL NUMBER (B)(4), HAD MINOR WEAR NOTED TO THE ROLLER GEAR AND CUTTER BLADES. THE 2:1 RATIO CUTTER, SERIAL NUMBER (B)(4), HAD MINOR WEAR NOTED TO THE ROLLER GEAR AND CUTTER BLADES. REPAIR OF THE SKIN GRAFT MESHER WAS PERFORMED BY ZIMMER BIOMET SURGICAL ON (B)(6) 2016 WHICH INCLUDED REPLACEMENT OF THE ROLLER, WORN BUSHINGS, WORN SIDE PLATES, DAMAGED COMB AND GEARS. THE 1.5:1 RATIO CUTTER, SERIAL NUMBER (B)(4), PRODUCED A PASSING CUT. THE 2:1 RATIO CUTTER, SERIAL NUMBER (B)(4), PRODUCED AN INCOMPLETE CUT AND WAS DEEMED NON-REPAIRABLE. THE SKIN GRAFT MESHER WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED. PRIOR TO REPAIR, THE TEST MESH AND CALIBRATION CHECK WERE UNABLE TO BE PERFORMED DUE TO THE BENT COMB. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE AND A ROOT CAUSE HAS BEEN ESTABLISHED. RECEIVED; HOWEVER, NOT YET EVALUATED.

Additional Manufacturer Narrative · 1

THIS COMPLAINT IS BEING REPORTED BY ZIMMER BIOMET AS (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE CUSTOMER RETURNED A SKIN GRAFT MESHER DEVICE FOR EVALUATION. THE CUSTOMER ALSO RETURNED A 1.5:1 RATIO CUTTER, SERIAL NUMBER (B)(4), AND A 2:1 RATIO CUTTER, SERIAL NUMBER (B)(4), FOR EVALUATION. ZIMMER BIOMET SURGICAL HAS NOT PREVIOUSLY REPAIRED/EVALUATED THE SKIN GRAFT MESHER. THE DEVICE HISTORY RECORD (DHR) REVIEW NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD), CHANGE NOTICES (CN) OR ANY OTHER ISSUES WITH MANUFACTURING. THE DHR REVIEW FOUND NO ISSUES WITH THE DEVICE AND ALL VERIFICATIONS, INSPECTIONS AND TESTS WERE SUCCESSFULLY COMPLETED. INITIAL QA INSPECTION OF THE SKIN GRAFT MESHER REVEALED MINOR COSMETIC DAMAGE TO THE MESHER HANDLE INCLUDING NICKS AND SCRATCHES. THE LATCHING PINS ENGAGE AS INTENDED. THE COMB WAS BENT ON THE RIGHT HAND SIDE. THERE WAS MINOR WEAR NOTED TO THE ROLLER GEAR. THE TEST MESH USING THE CUSTOMER¿S MESHER AND RATCHET WAS UNABLE TO BE PERFORMED DUE TO THE BENT COMB. THE RATCHET APPEARED TO RATCHET NORMALLY. THE 1.5:1 RATIO CUTTER HAD MINOR WEAR NOTED TO THE ROLLER GEAR AND CUTTER BLADES. THE 2:1 RATIO CUTTER HAD MINOR WEAR NOTED TO THE ROLLER GEAR AND CUTTER BLADES. REPAIR OF THE SKIN GRAFT MESHER WAS PERFORMED BY ZIMMER BIOMET SURGICAL WHICH INCLUDED REPLACEMENT OF THE ROLLER, WORN BUSHINGS, WORN SIDE PLATES, DAMAGED COMB AND GEARS. THE 1.5:1 RATIO CUTTER PRODUCED A PASSING CUT. THE 2:1 RATIO CUTTER PRODUCED AN INCOMPLETE CUT AND WAS DEEMED NON-REPAIRABLE. THE SKIN GRAFT MESHER WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED. THE REPORTED EVENT WAS CONFIRMED SINCE DURING THE INITIAL INSPECTION IT WAS NOTED THAT THE COMB WAS BENT ON THE RIGHT HAND SIDE. WHILE DURING THE INITIAL INSPECTION IT WAS NOTED THAT THE COMB WAS BENT ON THE RIGHT HAND SIDE, IT IS UNKNOWN WITH THE INFORMATION THAT WAS PROVIDED HOW THIS OCCURRED. THEREFORE, BASED ON THE INFORMATION THAT WAS PROVIDED THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE SPECIFICALLY DETERMINED. THE SKIN GRAFT MESHER WAS REPAIRED, TESTED AND RETURNED TO THE CUSTOMER.

Description of Event or Problem · 1

IT WAS INITIALLY REPORTED THAT THE DEVICE TORE THE SKIN. ADDITIONAL INFORMATION WAS RECEIVED ON SEPTEMBER 27, 2016 STATING THAT THE INITIAL GRAFT WAS NOT USEABLE AND AN ADDITIONAL UNPLANNED COLLECTION OF GRAFT WAS NECESSARY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
656282	ZIMMER SKIN GRAFT MESHER	EXPANDER, SURGICAL, SKIN GRAFT	FZW	ZIMMER SURGICAL, INC.		61378597

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other\| R