MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA BLADE PERF L115 TAN ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.027.038S

Device Problem Failure To Adhere Or Bond (1031)

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

Event Date 01/30/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting. Due to the intra-operative events, the device was not successfully implanted. As such, implant/explant dates are not applicable. Reporter phone number is not provided for reporting. Device is not distributed in the united states, but is similar to device marketed in the usa. The subject device has been received and the product evaluation is in progress. No conclusion can be drawn. A review of the device history records has been requested and is currently pending completion. 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 a surgery performed on (b)(6) 2018, surgeon was unable to lock the proximal femoral nail antirotation (pfna) blade. No consequence for the patient reported. Surgery was completed successfully. This report is for one (1) pfna blade perf l115 tan. This is report 1 of 1 for complaint (b)(4).

Event Description

It was further reported that there was forty five (45) minutes of surgical delay.

Manufacturer Narrative

Additional narrative: 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: PFNA BLADE PERF L115 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7363683
• MDR Text Key: 103276862
• Report Number: 8030965-2018-52329
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 04.027.038S
• Device Lot Number: L286867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No