MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GENTLE THREADS INTERFERENCE SCREW FULL THREAD; SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER

Catalog Number	905604
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: concomitant medical products, part (lot): 905257 (240534).G2: foreign - the event occurred in united arab emirates.The customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found that would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that during an initial procedure, two interference screws fractured.Half of one screw remains in the patient's bone tunnel.The surgeon indicated that it was not possible to remove it.The correct surgical technique was used.No other complications or impacts were reported due to this malfunction.Attempts have been made, and no further information has been provided.
Event or Problem Description
It was reported that during an initial hamstring tendon graft procedure, two interference screws fractured.Half of one screw remains in the patient's bone tunnel and is indicated to be stable without the potential for migration.The surgeon stated that removing it was not possible, and the case was completed with a bone post outside the tunnel for graft fixation.The correct surgical technique was used.No other complications or impacts were reported due to this malfunction.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b1; b2; b4; b5; d2; d6; g1; g3; g6; h1; h2; h6.Corrections to b1; b2; b5; d6; h1; h2, as the patient did not retain this product, additional information indicated the retained screw was part number 905257.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6; h10.The reported event is not confirmed.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: GENTLE THREADS INTERFERENCE SCREW FULL THREAD
• Common Device Name: SMOOTH OR THREADED METALLIC BONE FIXATION FASTENER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20130505
• Report Number: 0001825034-2024-02145
• Device Sequence Number: 3265589
• Product Code: HWC
• UDI-Device Identifier: 00880304003255
• UDI-Public: (01)00880304003255(17)260825(10)544900
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K041274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/25/2026
• Device Catalogue Number: 905604
• Device Lot Number: 544900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: 09/12/2024; 01/09/2025
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 10/04/2024; 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: H11
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown