MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 38MM-STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	412.213S
Medical Device Problem Codes	Entrapment of Device (1212); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024, the patient underwent a removal surgery for proximal femur due to cut-out.During the surgery, the locking screw could not be removed.Although cutting and removal with a carbide drill were considered, the surgeon decided not to perform a tha revision and fns removal, considering the prolongation of operation time and the impact on the patient due to bleeding.The surgery was completed with more than thirty minutes delay.Patient was stable.This report captures the locking screw could not be removed during the removal surgery.(b)(4) captures the cut out that occurred after the primary surgery.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Corrected: g1.Device history review: part number: 412.213s; lot number: 8934p05; manufacturing site: mezzovico; release to warehouse date: 22 jan 2024; expiration date: 01 jan 2034.A manufacturing record evaluation was performed for the sterile finished lot number, and no non-conformances were identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 38MM-STERILE
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 20517753
• Report Number: 8030965-2024-13140
• Device Sequence Number: 9056335
• Product Code: KTT
• UDI-Device Identifier: 07611819152342
• UDI-Public: (01)07611819152342(17)20340101(10)8934P05
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K000682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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
• Operator of Device: Health Professional
• Device Catalogue Number: 412.213S
• Device Lot Number: 8934P05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2024
• 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: PL 1-HO F/FEM NECK SYST TAN.; UNK - NAIL HEAD ELEMENTS: FNS BOLT.
• Patient Sex: Unknown