MAUDE Adverse Event Report: ZIMMER SURGICAL SA DUAL TRIGGER PIN DRVR 2.0-4.0; WIRE-DRIVING POWER TOOL ATTACHMENT

Model Number N/A

Device Problem Difficult to Insert (1316)

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

Event Date 05/26/2023

Event Type  malfunction  

Event Description

It was reported that pin collet would not hold the pin.This event is related to a malfunction that could potentially lead to a serious injury.However, no patient harm or further outcome was reported.

Manufacturer Narrative

(b)(4).Dhr review was performed.Device was 21 months old and is not out of box failure.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.The device was not returned for evaluation.Device is used for treatment.Complaints were reviewed and no further action is required.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: DUAL TRIGGER PIN DRVR 2.0-4.0
• Type of Device: WIRE-DRIVING POWER TOOL ATTACHMENT
• Manufacturer (Section D): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; 1228 plan-les-ouates; geneva CH-12 28; SZ CH-1228
• Manufacturer (Section G): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; 1228 plan-les-ouates; geneva CH-12 28; SZ CH-1228
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 18090373
• MDR Text Key: 327593714
• Report Number: 0008031000-2023-00040
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 00889024521315
• UDI-Public: (01)00889024521315(11)210813(10)5015150
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• 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: 89-8522-451-42
• Device Lot Number: 5015150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose