MAUDE Adverse Event Report: STRYKER TRAUMA KIEL K-WIRE, STERILE T2 FEMUR Ø3X285 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060050S
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event that k-wire, sterile t2 femur ø3x285 mm [packaging] was alleged of - packaging: insect outside sterile blister or pouch could be confirmed based on the image provided, only.Based on investigation, the root cause was attributed to a supplier related issue.The failure was caused by an inadequate packaging process / insufficient inspection specification.The device inspection revealed the following: the inspection was limited to the image provided within product inquiry.Evaluation revealed an insect between the clear tube and the pouch.Sealing seams and original packaging are still intact.Thus, the pollution must have occurred during the packaging process at our sub-supplier, which was not detected during inspection.A review of the device history for the reported lot did not indicate any abnormalities.
Event or Problem Description
In in-coming inspection at distribution, it was found that there was a foreign material (bug) in blister.No patient involvement, adverse consequences, delay or medical intervention.

• Brand Name: K-WIRE, STERILE T2 FEMUR Ø3X285 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8262022
• Report Number: 0009610622-2019-00052
• Device Sequence Number: 1699110
• Product Code: LXH
• UDI-Device Identifier: 04546540195852
• UDI-Public: 04546540195852
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 18060050S
• Device Lot Number: K083961
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2018
• Initial Report FDA Received Date: 01/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other