MAUDE Adverse Event Report: ZIMMER, INC. RUSH AWL 2.5MM DIAMETER REAMER; ELBOW INSTRUMENT

Catalog Number 31810616700

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 07/28/2016

Event Type  malfunction  

Manufacturer Narrative

The reamer was returned for evaluation.As returned, the awl is bent and has fractured at the base of the handle.Review of receiving inspection report for the device indicates the devices were manufactured to specifications.Inspection documentation shows all devices that were inspected met specifications.Wear & tear is seen that indicates successful use during a potential field age of approximately 10 years 10 months.Dimensional measurements are conforming to print specifications.The instrument was manufactured on september 22, 2005.This device is used for treatment.Initial product history search conducted on september 28th 2016 revealed no additional complaints against the related part and lot combination.Wear and tear has been determined to be the root cause for the instrument fracture.

Event Description

It is reported that the device was found to be fractured during kit inspection.

• Brand Name: RUSH AWL 2.5MM DIAMETER REAMER
• Type of Device: ELBOW 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6190321
• MDR Text Key: 63312870
• Report Number: 0001822565-2016-04753
• Device Sequence Number: 1
• Product Code: HWJ
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 31810616700
• Device Lot Number: 60351086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2016
• Date Manufacturer Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2005
• 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