FDA Adverse Event Malfunction Summary report: N

LOW PROFILE SELF-TAPPING BONE SCREW 6.5 MM X 25 MM

MDR report key: 2042675 · Received April 6, 2011

Report

Report Number: 1825034-2011-00262
Event Type: Malfunction
Date Received: April 6, 2011
Date of Event: March 8, 2011
Report Date: March 11, 2011
Manufacturer: BIOMET ORTHOPEDICS
Product Code: LPH
PMA / PMN Number: K991807
Removal / Correction Number: 1825034-2011-006R
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

EVALUATION OF RETURNED DEVICE CONFIRMED REPORTED CONDITION. DECISION WAS MADE TO RECALL BASED ON A MANUFACTURING ISSUE THAT WAS DETERMINED AS PART OF INTERNAL INVESTIGATION. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT PATIENT UNDERWENT HIP PROCEDURE ON (B)(6) 2011. DURING THE PROCEDURE, THE SURGEON MEASURED THE DEPTH FOR THE SCREW USING A DEPTH GAUGE AND DETERMINED THAT A 25MM SCREW WOULD BE NECESSARY. A 25MM SCREW PACKAGE WAS OPENED AND THE SCREW WAS IMPLANTED BUT AN INTEROPERATIVE RADIOGRAPH DETERMINED THAT THE SCREW WAS TOO LONG. THE SCREW WAS TAKEN OUT AND A 20MM SCREW WAS IMPLANTED. A MEASUREMENT WAS TAKEN USING CALIPERS FOR A DIFFERENT SCREW LOCATION AND AGAIN THE SURGEON DETERMINED THAT A 25MM SCREW WOULD BE NECESSARY. THE SURGEON IMPLANTED THE SAME 25MM SCREW BUT THE INTEROPERATIVE RADIOGRAPH AGAIN SHOWED IT WAS TOO LONG. THE SURGEON SUGGESTED THAT THE 25MM SCREW BE MEASURED AND WHEN IT WAS HELD TO A RULER, THE 25MM SCREW ACTUALLY MEASURED 30MM. A 20MM SCREW WAS USED TO COMPLETE THE PROCEDURE WITH NO INJURY TO THE PATIENT OR DELAY IN THE PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LOW PROFILE SELF-TAPPING BONE SCREW 6.5 MM X 25 MM	PROSTHESIS, HIP	LPH	BIOMET ORTHOPEDICS	N/A	427460

Patients

Seq	Age	Sex	Outcome	Treatment
1