MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5 MM / 2.7 MM LOCKING SCREW DEPTH GAUGE STANDARD; TRAUMA, INSTRUMENT

Catalog Number 00236004035

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports:0001822565 -2023 -01840.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up report will be submitted.H3 other text: product not returned.

Event Description

It was reported that the instruments fractured.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned products identified the depth gauge hook is fractured.The hook exhibits wear & tear that indicates repeated use during a potential field age greater than 9 years.The targeting device has one of two posts is fractured and missing.Wear & tear is seen that indicates repeated use during a potential field age greater than 8 years.Device history record was reviewed and no discrepancies were found.The reported even is confirmed as product was returned.The root cause of the reported issue is attributed to use error.The instruments were dropped.Ifu states "failure to follow these instructions could result in instrument or provisional breakage and potential adverse effects on user(s) or patient".If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: 3.5 MM / 2.7 MM LOCKING SCREW DEPTH GAUGE STANDARD
• Type of Device: TRAUMA, INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17297773
• MDR Text Key: 318957253
• Report Number: 0001822565-2023-01836
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• 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: 62538735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1