MAUDE Adverse Event Report: SYNTHES GMBH SCREW INSERTER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	03.037.025
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
After completing the successful insertion of a tfna nail, while reassembling the set after decontamination, it was found that the lag screw insertor and the lag screw insertor connecting screw had become inseparable.Due to overuse/general wear and tear, it seems like the internal threads connecting the two have become compromised.They were able to be forcefully separated for proper re-decontamination but the two are no longer case ready.There was no patient or user harm.
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 narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
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.H11 additional narrative: added: d10.H6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.Investigation summary.Product was not returned.Based on the information available, it has been determined that no corrective and 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.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.H11 additional narrative: added: d4 (lot, expiration), d9, h4.Corrected: d4 primary udi number.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.H11 additional narrative: corrected: g1 manufacturer site h3, h6: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found proximal end of the device is scratched, inner threads appeared to be stripped as well.An interaction was made using the helical blade/screw coupling screw and the screw inserter, devices were able to be assembled, however, attempts to disassemble both devices were unsuccessful.It can be concluded that the reported condition was able to be replicated based on the condition of the internal components of the screw inserter.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.A dimensional inspection was unable to be performed due to devices being unable to disassemble a functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the screw inserter would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot = > a manufacturing record evaluation was performed for the finished device product code: 03.037.025-us lot number: 2945p92 it was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 20 dec 2022 manufacturing site: jabil bettlach.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SCREW INSERTER
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach CO ; SZ
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 24333036
• Report Number: 8030965-2026-01519
• Device Sequence Number: 17398036
• Product Code: HSB
• UDI-Device Identifier: 10886982070418
• UDI-Public: (01)10886982070418(17)411231(10)2945P92
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,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: 03.037.025
• Device Lot Number: 2945P92
• 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: 01/30/2026
• Supplement Date Received by Manufacturer: 03/13/2026; 03/19/2026; 04/10/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/18/2026; 03/26/2026; 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HELICAL BLADE/SCREW COUPLING SCREW.
• Patient Sex: Unknown