MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L85 TAN ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.027.052S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Patient information not available for reporting. Device malfunctioned intra-operatively and was not implanted / explanted. (b)(6). Device is not distributed in the united states, but is similar to device marketed in the usa. A review of the device history records has been requested. Subject device has been received and is currently in the evaluation process. 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 surgeon was implanting the proximal femoral nail antirotation (pfna) ii system on unknown date. Surgeon was not able to lock the pfna blade due to lack of compression. Surgery was completed successfully with a delay of approximately 45 minutes and no harm to patient. This report is for one (1) pfna ii blade. This is report 1 of 1 for (b)(4).

Manufacturer 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.

Event Description

During manufacturer¿s preliminary analysis of the returned devices it was observed that a broken off bit is stuck in the blade. This is report 1 of 2 for complaint (b)(4).

• Brand Name: PFNA-II BLADE L85 TAN
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7567509
• MDR Text Key: 110034759
• Report Number: 8030965-2018-54115
• 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: 05/11/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 04.027.052S
• Device Lot Number: L292672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No