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 Known Impact Or Consequence To Patient (2692)
Date of Event	03/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device matched the report and the complaint failure mode was confirmed.Referring to product inquiry the k-wire, sterile t2 femur ø3x285 mm is stated to be the primary product.No further associated products were reported.A review of the dhr revealed no discrepancies.During the visual inspection a hair between the clear tube and the pouch was found.All seals 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.Based on the above facts the root cause of the reported event is related to an inadequate packaging process.No discrepancies were detected during risk analysis review.This case is transferred to already opened ncr #(b)(4) which is supplier related as well.
Event or Problem Description
In in-coming inspection at distribution, it was found that there was a foreign material (hair) in blister.This event was found on 1 of 35 units.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: 6483759
• Report Number: 0009610622-2017-00111
• Device Sequence Number: 623913
• Product Code: LXH
• UDI-Device Identifier: 04546540195852
• UDI-Public: (01)04546540195852(11)170209(17)220131(10)K0C956C
• 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): 04/11/2017

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: 01/31/2022
• Device Catalogue Number: 18060050S
• Device Lot Number: K0C956C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2017
• Initial Report FDA Received Date: 04/11/2017
• 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