FDA Adverse Event Malfunction Summary report: N

HP MBT CEM KEEL PUNCH SZ 4-7

MDR report key: 4250047 · Received November 14, 2014

Report

Report Number: 1818910-2014-31732
Event Type: Malfunction
Date Received: November 14, 2014
Date of Event: November 11, 2014
Report Date: November 11, 2014
Manufacturer: DEPUY ORTHOPAEDICS, INC. 1818910
Product Code: LXH
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NC, 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.

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.

Additional Manufacturer Narrative · 1

(B)(4). EXAMINATION OF THE RETURNED KEEL PUNCH CONFIRMS THAT BOTH TABS ARE FRACTURED. THE FRACTURED TABS WERE NOT RETURNED FOR EXAMINATION, HOWEVER THE INITIAL REPORT STATED NO PIECES WERE LEFT IN THE PATIENT. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE FRACTURES, HOWEVER HEAVY USAGE OVER TIME AND OR USER ERROR/MISUSE COULD BE CONTRIBUTING FACTORS. CAPA (B)(4) WAS PREVIOUSLY INITIATED TO IDENTIFY ROOT CAUSE AND ANY CORRECTIVE ACTIONS. 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.

Description of Event or Problem · 1

SIGMA TIBIAL KEEL PUNCH BROKE DURING SURGERY. TIBIAL KEEL CONNECTION CONTINUES TO BREAK THE POST ON THE KEEL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
736170	HP MBT CEM KEEL PUNCH SZ 4-7	KNEE INSTRUMENTS	LXH	DEPUY ORTHOPAEDICS, INC. 1818910		NB41327

Patients

Seq	Age	Sex	Outcome	Treatment
1	52 YR