MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM F/IM NAIL-STER; SCREW, FIXATION, BONE

Catalog Number	04.005.524S
Medical Device Problem Codes	Difficult to Advance (2920); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from japan reports an event as follows: it was reported that on (b)(6) 2024, the patient underwent an osteosynthesis for a subtrochanteric fracture of the femur.The surgeon drilled with a radiolucent drive, measured, and attempted to insert the locking screw.However, the insertion of the locking screw was too rigid to proceed, and the locking screw could only be inserted halfway.The surgeon pulled out that locking screw, re-drilled, and tried to insert the locking screw again, but could not, so the surgeon decided that the locking screw appeared to become stripped and inserted another locking screw.After that, the surgeon drilled carefully for the other hole of the nail, inserted a locking screw into it, and completed the surgery successfully with no surgical delay.There was no adverse patient impact.No additional information is available.This report is for a 5.0mm ti locking screw w/t25 stardrive 34mm f/im nail-ster.This is report 1 of 1 for (b)(4).
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.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: initial reporter is a synthes employee.H3, h6: 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.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part # 04.005.524s lot # 184l286 manufacturing site: werk selzach release to warehouse date: 01.Jun.2023 expiration date: 01.Jun.2033 supplier: (b)(4).A manufacturing record evaluation was performed for the not sterile finished lot number, and no non-conformances were identified.Part number: 04.005.524 lot number: 6107p45 manufacturing site: mezzovico release to warehouse date: 09 may 2023.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis revealed that the threads of the lockscr ø5 l34 f/nails tan light green was stripped.No other issues were observed.A functional test could not be performed as the mating device was not returned, however, the will not seat/advance allegation can be attributed to the striped condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the lockscr ø5 l34 f/nails tan light green would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM F/IM NAIL-STER
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH; bohackerweg 5; selzach CO 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18553586
• Report Number: 8030965-2024-01150
• Device Sequence Number: 15352669
• Product Code: HWC
• UDI-Device Identifier: 10886982085931
• UDI-Public: (01)10886982085931
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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: 04.005.524S
• Device Lot Number: 184L286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2024
• Supplement Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown