MAUDE Adverse Event Report: SYNTHES GMBH INSERTION HANDLE F/ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.010.226
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from colombia reports an event as follows: it was reported that during an unknown procedure on (b)(6) 2023, the protection sleeve did not fit into the 125 hole.There was no patient impact, the surgeon decided to implant the screws in the head.No additional information is available to report.This report is for an insertion handle f/adolescent lateral entry femoral nail-ex.This is report 1 of 2 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.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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# 03.010.226, lot # 1l49267, manufacturing site: werk hägendorf, supplier: na, release to warehouse date: 11 oct 2018, expiration date: na.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 this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: INSERTION HANDLE F/ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HAEGENDORF; im bifang 6; haegendorf CO 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17838093
• Report Number: 8030965-2023-12335
• Device Sequence Number: 15370380
• Product Code: LXH
• UDI-Device Identifier: 10886982068088
• UDI-Public: (01)10886982068088
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.010.226
• Device Lot Number: 1L49267
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2018
• 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: PROTECT SLEEVE 12/8 L188; UNK - SCREWS: TRAUMA
• Patient Sex: Unknown