MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LINKED LAG SCREW INSERTER; TRAUMA, INSTRUMENT

Catalog Number 00119301200

Device Problem Fracture (1260)

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

Event Date 01/04/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.

Event Description

It was reported that the product had 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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified the end that accepts the lag screw is fractured with all of pieces not returned.Wear and tear is seen on the broken fragment indicating repeated use.Complaint is confirmed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.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.

Event Description

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

• Brand Name: LINKED LAG SCREW INSERTER
• 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: 16266929
• MDR Text Key: 308624368
• Report Number: 0001822565-2023-00256
• Device Sequence Number: 1
• Product Code: HWR
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00119301200
• Device Lot Number: 60426596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/04/2023
• Initial Date FDA Received: 01/30/2023
• Supplement Dates Manufacturer Received: 04/18/2023
• Supplement Dates FDA Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1