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

Catalog Number 00119301200

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 10/07/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: (b)(6).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.Product not returned.

Event Description

It was reported that the instrument fractured.

Manufacturer Narrative

Visual examination of the returned product identified the end that engages the lag screw is cracked.Material hardness is conforming to print specification and the device has a potential field age of approximately 16 years 6 months.Device history record was reviewed and no discrepancies were found.Root cause was unable to 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: EXTREMITIES, INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10810202
• MDR Text Key: 215335002
• Report Number: 0001822565-2020-03780
• Device Sequence Number: 1
• Product Code: HWR
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

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: 60139322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1