MAUDE Adverse Event Report: SYNTHES GMBH RADIOLUCENT INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.010.405
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2022
Type of Reportable Event	Malfunction
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.Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Date of concomitant therapy is (b)(6)2022.Without a lot number the device history records review could not be completed.Product was not returned.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.
Event or Problem Description
Device report from synthes reports an event in japan as follows: it was reported that on (b)(6)2022, the patient underwent surgery for femoral intertrochanteric fracture.There was no interference during dry check before nail insertion.The surgeon inserted the nail without using a combination hammer.After blade insertion, the insertion handle and nail were slightly loose, so the surgeon retightened them with an onion screwdriver and replaced them with another aiming arm to drill the distal lateral stop and was able to perform drilling without interference.The procedure was successfully completed.No further information is available.This report is for a radiolucent insertion handle f/trochanteric fixation nails.This is report 1 of 2 for pc-(b)(4).

• Brand Name: RADIOLUCENT INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15713849
• Report Number: 8030965-2022-09112
• Device Sequence Number: 4924086
• Product Code: LXH
• UDI-Device Identifier: 07611819349421
• UDI-Public: (01)07611819349421
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 10/31/2022

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: 03.010.405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: AIM-ARM 130° F/PFNA BLADE; AIM-ARM F/STAT LOCK F/PFNA-II STD; CONNECT-SCR-CANN F/PFN+PFNA; UNK - NAILS: PFNA; UNK - SCREWDRIVERS
• Patient Sex: Unknown