MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH ROD, FIXATION, INTRAMEDULLARY

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown. The 510k: this report is for an unknown tfna blade/unknown lot. Part and lot numbers are unknown; udi number is unknown. Unknown if/when the device was explanted. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Initial reporter phone number was not provided. Initial report is a synthes sales consultant. 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 post-operatively the trochanteric fixation nail anti-rotation (tfna) blade cut through the head of the femur. Concomitant reported part: tfna nail (part/lot unknown, quantity 1). This report is for an unknown tfna blade. This is report 1 of 1 for (b)(4).

• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf ; SZ
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7176142
• MDR Text Key: 96779636
• Report Number: 8030965-2018-50185
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 01/09/2018 Patient Sequence Number: 1