MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER PERIARTICULAR LOCKING PLATE DEPTH GAUGE; TRAUMA INSTRUMENT

Catalog Number 00236004035

Device Problem Break (1069)

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

Event Date 08/10/2016

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported the depth gauge broke during surgery.All pieces were retrieved from the patient.

Manufacturer Narrative

This report will be amended when our investigation is complete.Received, but not yet evaluated.

Manufacturer Narrative

Device history records were reviewed with no deviations or anomalies identified that would have contributed to the reported event.The depth gauge was returned for review.Visual inspection confirms the fracture, with the fractured piece also returned.Dimensions were found conforming to print specifications where measured.This device is used for treatment.An initial product history search conducted (b)(6) 2016 revealed no additional complaints against the related part and lot.The device was manufactured on 27 dec, 2014, with the described event occurring on (b)(6) 2016; therefore, the device had a potential field age of approximately 1 year 8 months with its field usage unknown.It was indicated that the surgical technique was followed, therefore, a definitive root cause for the fracture cannot be determined with the information provided.

• Brand Name: ZIMMER PERIARTICULAR LOCKING PLATE DEPTH GAUGE
• 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: 5935465
• MDR Text Key: 54675019
• Report Number: 0001822565-2016-03126
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: UY
• 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,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: 00236004035
• Device Lot Number: 62918284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2014
• 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