FDA Adverse Event Malfunction Summary report: N

DRILL, TRI-FLAT T2 TIBIA Ø3,5X130 MM

MDR report key: 3882563 · Received June 19, 2014

Report

Report Number: 0009610622-2014-00278
Event Type: Malfunction
Date Received: June 19, 2014
Date of Event: May 29, 2014
Report Date: May 29, 2014
Manufacturer: STRYKER TRAUMA KIEL
Product Code: HWE
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

EVALUATION SUMMARY: THE RETURNED DEVICE MATCHED THE REPORT AND THE REPORTED EVENT WAS CONFIRMED. REVIEW OF THE INSPECTION RECORDS REVEALED NO DISCREPANCIES. THE ITEM RETURNED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. THE TIP OF THE DRILL IS SIGNIFICANTLY COMPRESSED, FLATTENED AND DEFORMED. MATERIAL HAS BEEN DISPLACED. THE APPEARANCE AND THE EXTENT OF THE DAMAGE AT THE TIP INDICATE THAT THE DRILL HAD BEEN OPERATED UNDER HIGH FORCES. THE TIP OF THE DRILL HAD BEEN PRESSED AGAINST A HARD OBJECT, WHICH HAD LED TO THE SIGNIFICANT COMPRESSION AND FLATTENING OF THE TIP. AS THE DRILL HAD BEEN IN USE FOR A LONGER TIME (MANUFACTURED IN 2012) WE PRE-SUPPOSE THAT THE DEVICE HAD FULFILLED ITS TASKS IN FORMER SURGERIES AS INTENDED. BASED ON THE ABOVE FACTS THE ROOT CAUSE OF THE REPORTED EVENT IS NOT RELATED TO A DEFICIENCY OF THE DEVICE, BUT RATHER LINKED TO IMPROPER HANDLING. NO NON-CONFORMITY WAS IDENTIFIED.

Description of Event or Problem · 1

DURING THE INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE TIP OF DRILL BROKE. ACCORDING TO SALES REP, THE TIP OF DRILL BROKE DURING WASHING OF AN INSTRUMENT AFTER THE OPERATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
361855	DRILL, TRI-FLAT T2 TIBIA Ø3,5X130 MM	SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTACHMENTS	HWE	STRYKER TRAUMA KIEL		K239637

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other