MAUDE Adverse Event Report: SYNTHES GMBH HELICAL BLADE COUPLING SCREW; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	357.377
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from depuy synthes reports an event in united kingdom as follows: it was reported that on (b)(6) 2022 during trochanteric fixation nail (tfn) removal case, the t handle for removal of the lag screw and the connecting pin were damaged.The tfn nail was unable to be removed due to this damage leading patient being closed without the nail being removed.There was difficulty getting the ¿flats¿ of the t handle to ¿mate¿ properly with the end of the lag screw.Due to this the flats for the t handle bent outwards and the thread of the cannulated connecting pin snapped off in the lag screw.The implant was not able to be removed as planned.This report is for one (1) helical blade coupling screw.This is report 2 of 2 for complaint (b)(4).
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j sales representative.Without a lot number the device history records review could not be completed.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.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Part # 357.377 synthes lot # h024048 supplier lot # h024048 release to warehouse date: 01 june 2016 supplier: (b)(4) no ncrs were generated during production.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the connecscr f/helical blade f/tfn was broken from the threaded tip, fragment was not returned.Assembling issues are most likely due to this condition.Embedded device condition cannot be confirmed since x-ray evidence was not provided.A dimensional inspection and a functional test for the connecscr f/helical blade f/tfn were unable to be performed due to post manufacturing damage and since mating device was not returned.The complaint condition was not able to be replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the connecscr f/helical blade f/tfn would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: HELICAL BLADE COUPLING SCREW
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 15612069
• Report Number: 8030965-2022-08219
• Device Sequence Number: 17934481
• Product Code: LXH
• UDI-Device Identifier: 07611819737594
• UDI-Public: (01)07611819737594
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 357.377
• Device Lot Number: H024048
• 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: 09/30/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2016
• 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: INSERTER/EXTRACTOR FOR TFN FEMORAL NECK; UNK - SCREWS: TRAUMA; UNK-TFN NAIL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown