inforMED
InjuryBWN

UNK DEPUY HAND TABLE

Received Sep 3, 2009

Report 1818910-2009-04706 · MDR key 1464320

Device

Generic name

Instrumentation

Model number

NA

Catalog number

UNK

Lot number

UNK

Product problems

  • Unknown (for use when the device problem is not known)

Patient

NA

  • Burn(s)

Narrative

Description of Event or Problem

SUIT PAPERS ALLEGE THAT DURING SURGERY FOR CARPEL TUNNEL RELEASE ON THE RIGHT HAND, THE PT'S ELBOW "WAS BURNED IN TWO PLACES BY WHAT WAS BELIEVED TO BE THE DEPUY HAND TABLE."

Additional Manufacturer Narrative

EXAMINATION WAS POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. THE INVESTIGATION WAS LIMITED TO REVIEW OF THE INFORMATION PROVIDED, AS THE PART AND LOT NUMBER REQUIRED TO REVIEW THE DEVICE HISTORY RECORDS WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADD'L INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

Remedial action

  • Other