MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DRIVER FOR LOCKING SCREW; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 5881-26

Device Problem Fracture (1260)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/06/2021

Event Type  Injury  

Event Description

It was reported that during a revision knee procedure, the hex driver fractured while attempting to decouple the knee prosthesis.The procedure was unable to be completed at that time.Due diligence is complete as multiple attempts were made; however, no further information or product has been received.

Manufacturer Narrative

(b)(4).Report foreign source: germany.Visual and dimensional evaluations could not be performed as no product was returned nor were pictures provided.Device history record was reviewed and no discrepancies related 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.

Manufacturer Narrative

Additional information provided does not alter previously reported investigation results.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 at time of this report.

Manufacturer Narrative

Additional information provided does not alter previously reported investigation results.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

It was reported that a patient underwent a total knee arthroplasty on an unknown date.Subsequently, on an unknown timeframe post implantation, the patient was scheduled for a debridement procedure with an articular surface exchange.During the surgery, the hex driver fractured while attempting to decouple the knee prosthesis.The surgeon therefore modified the surgical procedure as the articular surface was unable to be exchanged as planned.The patient is not scheduled for another surgery at this time.It was reported that no further information is available.

• Brand Name: DRIVER FOR LOCKING SCREW
• Type of Device: ORTHOPEDIC MANUAL SURGICAL 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: 15314666
• MDR Text Key: 298862641
• Report Number: 0001822565-2022-02470
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00889024199958
• UDI-Public: (01)00889024199958(10)64525774
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5881-26
• Device Catalogue Number: 00588102600
• Device Lot Number: 64525774
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 86 KG