MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PFNA-II BLADE L90 TAN ROD, FIXATION INTRAMEDULLARY

Catalog Number 04.027.053S

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting. Due to the intra-operative events,it is unknown if the device was successfully implanted. (b)(6). The (510k):unknown device is not distributed in the united states, but is similar to device marketed in the usa. 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)(4) as follows: it was reported that a proximal femoral nail antirotion (pfna-ii) blade cannot lock during an unknown orthopaedic procedure on (b)(6) 2018. It is unknown if there was a surgical delay. Patient and surgical outcome is unknown. Concomitant device: unknown pfna-ii nail (part#unknown, lot#unknown, quantity#unknown). This complaint involves one (1) device. This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: corrected data: 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-II BLADE L90 TAN
• Type of Device: ROD, FIXATION INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7868506
• MDR Text Key: 119956368
• Report Number: 8030965-2018-56238
• 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,Followup
• Report Date: 08/26/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 04.027.053S
• Device Lot Number: L859632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/06/2018

Is This a Reprocessed and Reused Single-Use Device?