MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER NATURAL NAIL CM LAG SCREW REAMER; TRAUMA INSTRUMENT

Catalog Number 00249003244

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/09/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that during the placement of the 3.2 mm lag screw pin the pin seemed to be bent slightly superiorly when passing through the femoral neck.Afterwards, the distal tip of lag screw reamer had separated from the lag screw reamer.There was a reported 30 minute delay in surgery.Another sterile tray of the cm nail instruments was opened and its lag screw reamer was used to complete the remainder of the case.The x-rays were reviewed by the surgeon following the procedure and it was noted by the surgeon that the patient has a large tumor in the femoral neck, which may have inhibited the 3.2mm guide pin from being placed straight.

Manufacturer Narrative

This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.The reamer was received for evaluation.It was found that the tip of the reamer blade is fractured off.The fractured piece was not returned.The reamer blade was within specification for hardness but is dull and show signs of wear.The device history records were reviewed and no deviations or anomalies were identified.This device is used for treatment.The complaint history review was conducted for the device and found no additional complaints for the same lot.A definitive root cause of the reported issue cannot be determined with the information provided.However a surgeon ¿highlighted a large tumor in the femoral neck and stated his belief that it could have caused the bend in the 3.2 mm guide pin.¿.

• Brand Name: ZIMMER NATURAL NAIL CM LAG SCREW REAMER
• Type of Device: TRAUMA INSTRUMENT
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5936498
• MDR Text Key: 54218573
• Report Number: 0001822565-2016-03129
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00249003244
• Device Lot Number: 63053389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1