MAUDE Adverse Event Report: SYNTHES GMBH EXTRACTION HOOK FOR TI CANNULATED NAILS; MISC ORTHO SURGICAL INSTR

Catalog Number	355.399
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the underwent for a revision surgery due to non-union.It was reported that in (b)(6) 2016 the patient underwent for the open reduction internal fixation surgery for right femoral trochanteric fracture with the tfna nail.During the revision surgery on (b)(6) 2020, it was found that the nail had been broken under trochanteric femur.The surgeon unable to remove the nail due to extraction hook couldn¿t hold the nail firmly and closed the incision.The reoperation was schedule.The surgery was completed with 210 minutes delay.The patient outcome was unknown.Concomitant device reported: unknown nail (part# unknown, lot# unknown, quantity 1).This complaint involves one (1) device.This report is for (1) extraction hook for ti cannulated nails.(b)(4).

• Brand Name: EXTRACTION HOOK FOR TI CANNULATED NAILS
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10896251
• Report Number: 8030965-2020-09173
• Device Sequence Number: 11514451
• Product Code: LXH
• UDI-Device Identifier: 07611819709560
• UDI-Public: (01)07611819709560
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/29/2020

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: 355.399
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 11/24/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - NAILS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR