MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 12MM UNIVERSAL FEMORAL NAIL 380MM; NAIL,FIXATION,BONE

Catalog Number 274.220

Device Problem Bent (1059)

Patient Problem No Code Available (3191)

Event Date 02/13/2018

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Patient code 3191 used to capture additional medical/surgical intervention required.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.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 Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during the surgery on (b)(6) 2018, when the surgeon introduced the femoral nails 12x380 and 11x400, using the image intensifier, the surgeon observed that the nails were bent.This caused the nail holes for the screws (which maintain the nail on its position) to be in the wrong place, making it impossible to put the locking bolts.The surgeon used a different sized nail to complete the procedure.There was no report of patient harm.This report is for one (1) 12mm universal femoral nail 380mm.This is report 1 of 2 for complaint (b)(4).

Event Description

Concomitant devices reported: screws (part# unknown, lot# unknown, quantity unknown).

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.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.

• Brand Name: 12MM UNIVERSAL FEMORAL NAIL 380MM
• Type of Device: NAIL,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7433336
• MDR Text Key: 105587411
• Report Number: 8030965-2018-53129
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 10886982173263
• UDI-Public: (01)10886982173263
• Combination Product (y/n): N
• PMA/PMN Number: K914371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 274.220
• Device Lot Number: 252280
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention