MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MOD ARTHRO 5 DEG LCK COLLAR; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign country: (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 mdr will be submitted.

Event Description

It was reported that during the change of a 5 degree connector, 3 screws broke off while inserting the new implant.No adverse events have been reported as a result of the malfunction.Additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of photographs received.Visual examination of the provided pictures found 3 of the small screws have fractured.The device was not returned for further evaluation.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event 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 report 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: d9; h2; h3; h6.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned device found 3 of the small locking collar screws have fractured at the base of the threads off in component cp260601-01 and the exhibit damage to the hex.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Device was submitted for further analysis.Analysis determined the screw fractured due to torsional overload.Eds semi-quantitative elemental analysis of the collar bolt showed that it was consistent with ti-6al-4v alloy.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.It was reported the tourque limit was set at 55 in-lb.This is correct per the oss modular arthrodesis system assembly guide.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.

Event Description

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

• Brand Name: MOD ARTHRO 5 DEG LCK COLLAR
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11202328
• MDR Text Key: 228177150
• Report Number: 0001825034-2021-00099
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00880304082984
• UDI-Public: (01)00880304082984
• Combination Product (y/n): N
• PMA/PMN Number: K042409
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• 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: CP260601
• Device Lot Number: 250840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1