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

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 10/23/2023

Event Type  malfunction  

Event Description

It was reported that the fractured lag screw fractured during a primary surgery.There was no patient harm or impact.Attempts have been made and there is no further information at this time.

Manufacturer Narrative

(b)(4).H3: product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

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

Manufacturer Narrative

(b)(4).Updated: b4, b5, d2, g3, h1, h2, h3, h4, h6, h10 reported event was confirmed as visual examination of the returned product identified inserter drive shaft is fractured.Wear & tear is seen that indicates repeated use during a potential field age greater than 19 years.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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.

• Brand Name: LINKED LAG SCREW INSERTER
• Type of Device: TRAUMA INSTRUMENTS
• 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: 18168944
• MDR Text Key: 328527757
• Report Number: 0001822565-2023-03193
• Device Sequence Number: 1
• Product Code: HWR
• UDI-Device Identifier: 00889024036123
• UDI-Public: (01)00889024036123
• 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: 02/16/2024

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 Model Number: N/A
• Device Catalogue Number: 00119301200
• Device Lot Number: 60199460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: 02/07/2024
• Supplement Dates FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2004
• 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
• Patient Age: 16 YR
• Patient Sex: Female