MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 36MM F/IM NAIL-STER; SCREW, FIXATION, BONE

Model Number	04.005.526S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Malunion of Bone (4529)
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent the open reduction internal fixation (orif) with the trochanteric fixation nail advanced (tfna) system for the fracture of the trochanteric femur.The fracture was intramedullary, and the proximal fragment displaced posteriorly.The surgeon tried to reduce the fracture; however, it did not go well, and the fracture was fixed with subtype n (ikuta classification).The surgery was completed without any surgical delay.Intramedullary fixation was observed a few days after the surgery.Recently, the patient complained of pain, and it was confirmed that the pseudoarthrosis occurred.The revision surgery for removal of the implants and the total hip arthroplasty was performed on (b)(6) 2022.This report is for a locking screw.This is report 3 of 4 for (b)(4).
Additional Manufacturer Narrative
Patient height reported as 175 centimeters.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch 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.H10 additional narrative: h4 device history sterile part: part #: 04.005.526s.Lot #: 7l65744.Manufacturing site: werk selzach.Supplier: früh (b)(4).Release to warehouse date: 07 dec 2020.Expiration date: 01 dec 2030.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Non-sterile part: part #: 04.005.526.Lot #: 79p6023.Manufacturing site: mezzovico.Release to warehouse date: 26 nov 2020: a manufacturing record evaluation was performed for the not sterile lot number, and no non-conformances were identified.Device was used for treatment, not diagnosis.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 SCREW W/T25 STARDRIVE 36MM F/IM NAIL-STER
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14026669
• Report Number: 8030965-2022-02229
• Device Sequence Number: 5947858
• Product Code: HWC
• UDI-Device Identifier: 10886982085955
• UDI-Public: (01)10886982085955
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K000089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 04.005.526S
• Device Catalogue Number: 04.005.526S
• Device Lot Number: 7L65744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TFNA END CAP EXTENS. 5 TAN; TFNA FEM NAIL Ø12 130° L200 TIMO15; TFNA HELICAL BLADE L110 TAN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 75 KG