MAUDE Adverse Event Report: SYNTHES (USA) IMPACTOR F/PFNA BLADE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 03.010.410

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).Device is an instrument and is not implanted/explanted.(b)(6).Device is not distributed in the united states.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.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 (b)(4) reports an event in (b)(6) is as follows; it was reported that a proximal femoral nail antirotation (pfna) impactor f/pfna blade broke and is stuck in a pfna blade perf l100 tan.It is unknown how this event occurred and whether there was any patient involvement.This is report number 3 of 3 for (b)(4).

• Brand Name: IMPACTOR F/PFNA BLADE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6067364
• MDR Text Key: 58771568
• Report Number: 2520274-2016-15129
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1