MAUDE Adverse Event Report: ZIMMER BIOMET, INC. THREADED TIP STEINMANN PIN 1/8 DIAMETER 2.5 INCH LONG; INSTRUMENT, SHOULDER

Model Number N/A

Device Problems Fracture (1260); Mechanical Jam (2983)

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

Event Date 04/21/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).D10 - concomitant devices - vanguard knee shortquick-release drill catalog #: 32-486259 lot #: ni.G2 - report source - foreign: event occurred in canada.The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.This report was previously submitted on may 9, 2023 and jun 12, 2023 under manufacturing report number 0001825034-2023-01013.

Event Description

It was reported that during a shoulder arthroplasty, the pin became jammed in the pin driver and subsequently fractured.The pin could not be removed.No adverse events were reported as a result of this malfunction.

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.The following sections were updated: b4, g3, g6, h2, h3, h6, h10.Visual evaluation of a picture provided confirmed that the pin was locked in the driver and had snapped off.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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: THREADED TIP STEINMANN PIN 1/8 DIAMETER 2.5 INCH LONG
• Type of Device: INSTRUMENT, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17741348
• MDR Text Key: 323368132
• Report Number: 0001825034-2023-02166
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00887868505232
• UDI-Public: (01)00887868505232(17)320112(10)263790
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• 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: 406669
• Device Lot Number: 263790
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Sex: Prefer Not To Disclose