FDA Adverse Event Injury Summary report: N

4.0MM TROCAR 176MM

MDR report key: 2994053 · Received February 27, 2013

Report

Report Number: 2530088-2013-10196
Event Type: Injury
Date Received: February 27, 2013
Date of Event: May 25, 2011
Report Date: May 25, 2011
Manufacturer: SYNTHES (USA) BRANDYWINE
Product Code: FZX
PMA / PMN Number: EXEMPT
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED 02/2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. IT IS REPORTED THAT THE PT IS (B)(6). THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED SOME MINOR DINGS ON THE TOP SURFACE AND THE POINT. THERE IS SOME DISCOLORATION AROUND WHERE THE SHAFT AND HEAD MEET. THE PRODUCT INVESTIGATION REVEALED THAT THE COMPLAINT S DEEMED INVALID. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A HIP FRACTURE TFN FIXATION SURGERY, THE SURGEON INSERTED THE TFN AND WHEN HE WENT TO INSERT THE HELICAL BLADE, THE BLADE KEPT HITTING THE EDGE OF THE NAIL. THE SURGEON TRIED REALIGNING SEVERAL TIMES AND NOTHING HELPED. THE DISTAL LOCKING HOLE WAS ALSO OUT OF ALIGNMENT. THE SURGERY WAS DELAYED BY THIRTY MINUTES DUE TO MALFUNCTIONING DEVICES. THIS IS EVENT 12 OF 14 FOR THIS REPORT. THIS COMPLAINT IS ON 4.0MM TROCAR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
83814	4.0MM TROCAR 176MM		FZX	SYNTHES (USA) BRANDYWINE		4588829

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention