MAUDE Adverse Event Report: ZIMMER, INC. NEXGEN DRILL PIN AND SCREW INSERTER; KNEE INSTRUMENT

Catalog Number 00590102100

Device Problem Disassembly (1168)

Patient Problem No Information (3190)

Event Date 09/29/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that during surgery, the pin of the device dropped and it is unknown if the patient retained the piece.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Confirmed that this was not an adverse event.No product was returned; visual and dimensional evaluations could not be performed and the complaint could not be confirmed.Both the device history records and the receiving inspection report were reviewed and no deviations or anomalies were identified.It was reported that the surgical technique was followed.However, the exact conditions under which the fracture of the pin occurred remain unknown.This device was produced on 05-feb-2012 and therefore, had been in service for over 4 years.It is unknown how many times the device was used during that time.Per the package insert of this instrument, end of life is determined by wear and damage due to use.Also, the insert recommends to inspect all instruments carefully prior to each use, and to functional test instruments with long slender features (particularly rotating instruments) for distortion.If damage or wear is noted that may compromise the function of the instrument, it should not be used.A definitive root cause cannot be determined with the information provided.

Event Description

It was reported that during the surgery the pin dropped.Additional information received confirmed that no piece was retained by the patient.

• Brand Name: NEXGEN DRILL PIN AND SCREW INSERTER
• Type of Device: KNEE 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: kathleen smith ; p.o. box 708; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6052125
• MDR Text Key: 58216406
• Report Number: 0001822565-2016-03870
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00590102100
• Device Lot Number: 61988276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2016
• Initial Date FDA Received: 10/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/05/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other