MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II Ø12 XS 130° L170 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 472.107S

Device Problem Failure to Align (2522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Device was implanted, as such explant date is not applicable.Complainant part is not expected to be returned for manufacturer review/investigation.The (510k): device is not distributed in the united states, but is similar to device marketed in the usa.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.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that an open reduction internal fixation (orif) was performed on (b)(6) 2018 to treat the trochanteric fractures of the lateral femur.During the procedure, when the surgeon inserted a guide wire, the guide wire came off.So, the surgeon pushed the guide wire back by hand, and then inserted proximal femoral nail-antirotation (pfna) blade, but the blade happened to be inserted out of a nail¿s hole.The blade was re-inserted into the nail¿s hole, which resulted in 40 minutes of the surgical delay.There was no adverse consequence to the patient.The procedure was completed successfully.This report is for one (1) pfna nail.This is report 1 of 3 for complaint (b)(4).

• Brand Name: PFNA-II Ø12 XS 130° L170 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7651929
• MDR Text Key: 112859093
• Report Number: 8030965-2018-54735
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819837324
• UDI-Public: (01)07611819837324
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 472.107S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1