FDA Adverse Event Malfunction Summary report: N

RECLAIM ASSEM UPPER PULL ROD

MDR report key: 4003301 · Received August 12, 2014

Report

Report Number: 1818910-2014-25468
Event Type: Malfunction
Date Received: August 12, 2014
Date of Event: July 18, 2014
Report Date: July 18, 2014
Manufacturer: DEPUY ORTHOPAEDICS, INC. 1818910
Product Code: LXH
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative · 1

EXAMINATION OF THE RETURNED DEVICE CONFIRMS THREAD DAMAGE TO THE PULL ROD. A COMPLAINT DATABASE SEARCH ON THE RECLAIM ASSEM UPPER PULL ROD (B)(4) IDENTIFIED SIMILAR REPORTS OF THREAD DAMAGE WHICH WERE ATTRIBUTED TO MISUSE. THE ROOT CAUSE IS ATTRIBUTED TO INADVERTENT USER ERROR. BASED ON THE PERFORMED INVESTIGATION, CORRECTIVE ACTION IS NOT NEEDED. CONTINUE TO MONITOR VIA SEP-419. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

Additional Manufacturer Narrative · 1

THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

Description of Event or Problem · 1

INTERNAL THREAD OF DISTAL STEM DID NOT ENGAGE WITH TAPPER ASSEMBLY TOOL. COULD NOT BREAK THE TENSILE BAR. ALSO HAD DIFFICULTY THREADING NECK TRIAL TO STEM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
480864	RECLAIM ASSEM UPPER PULL ROD	HIP INSTRUMENT/TRIAL	LXH	DEPUY ORTHOPAEDICS, INC. 1818910		SO2003221

Patients

Seq	Age	Sex	Outcome	Treatment
1