MAUDE Adverse Event Report: ZIMMER, INC. BONE SCREW DRILL 3.2 MM DIAMETER; INSTRUMENT

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 11/18/2016

Event Type  malfunction  

Event Description

It was reported that during surgery the tip of the 3.2 bone screw drill fractured.There were no complications or delays reported.

Manufacturer Narrative

No devices were returned for further inspection, therefore the condition of the device is unknown.The lot number of the device was not reported and therefore the approximate field age could not be determined.The device history records for this device could not be reviewed as the lot information is unknown.This device is used for treatment.Per the manual orthopaedic surgical instructions, before use "visually inspect for completeness, damage, and/or excessive wear." based upon the available information, no definitive root cause can be determined.

• Brand Name: BONE SCREW DRILL 3.2 MM DIAMETER
• Type of Device: 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: 6181270
• MDR Text Key: 62679072
• Report Number: 0001822565-2016-04695
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PEXEMPT
• 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: 02/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00512008500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1