FDA Adverse Event Malfunction Summary report: N

K-WIRE GAMMA Ø3,2X450 MM

MDR report key: 5512947 · Received March 20, 2016

Report

Report Number: 0009610622-2016-00143
Event Type: Malfunction
Date Received: March 20, 2016
Date of Event: February 22, 2016
Report Date: February 22, 2016
Manufacturer: STRYKER TRAUMA KIEL
Product Code: LXH
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS NOT RETURNED. THE (B)(4) WAS OPENED FOR LOT CODE K04C0D2 AS THIS A POTENTIAL MIXUP PARTNER FOR LOT CODE K04D209. A DETAILED INVESTIGATION ON THE RETURNED ITEM FROM LOT CODE K04D209 WAS PERFORMED. HOWEVER NCR (B)(4) WAS OPENED IN ORDER TO ADDRESS FURTHER ACTIONS. THERE IS A MISMATCH BETWEEN THE LOT CODE (K04D209) ON THE ORDER LABEL ON THE OUTER PACKAGING (CLEAR TUBE) AND THE LOT CODE (K04C0D2) INDICATED ON THE INNER LABEL (STERILE POUCH) AND PATIENT RECORD LABELS AS WELL AS THE ENGRAVING ON THE K-WIRE ITSELF. THE DHR REVIEW SHOWED THAT THE LOTS K04D209 AND K04C0D2 FOR K-WIRE GAMMA Ø3,2X450 MM, CATALOGUE NUMBER 12106450S HAD BEEN PACKED AND LABELLED BY SUPPLIER STERIPACK ON THE SAME DAY BY DIFFERENT OPERATORS. THE NON-CONFORMANCE MUST HAVE OCCURRED HERE. INCOMING INSPECTION DID NOT DETECT THE NON-CONFORMANCE. THE REPORTED EVENT WAS CAUSED BY A PACKAGING/LABELLING ERROR AT THE SUPPLIER NOT DETECTED BY INSPECTION. NCR (B)(4)WAS OPENED IN ORDER TO ADDRESS FURTHER ACTIONS.

Description of Event or Problem · 1

IT WAS REPORTED BY THE STRYKER (B)(4) WAREHOUSE, THAT "UPON RECEIPT, IT WAS OBSERVED THAT THE LOT NUMBER OF THE OUTER LABELLING IS DIFFERENT THAN THE PATIENT LABEL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
168990	K-WIRE GAMMA Ø3,2X450 MM	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT	LXH	STRYKER TRAUMA KIEL		K04C0D2

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other