MAUDE Adverse Event Report: STRYKER TRAUMA KIEL K-WIRE, STERILE T2 FEMUR Ø1,8X310 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	01520218S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
In-incoming inspection at distribution, it was found that there was a foreign material in blister.No patient involvement, adverse consequences, delay or medical intervention.
Event or Problem Description
In-incoming inspection at distribution, it was found that there was a foreign material in blister.No patient involvement, adverse consequences, delay or medical intervention.
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 ø1,8x310 mm [packaging] is stated to be the primary product.During the visual inspection of the item received a hair was found out of the sterile barrier between the clear tube and the pouch within the secondary packaging.According to details received it was detected during ¿in-coming inspection¿.A review of the dhr revealed no discrepancies.Sealing seams and original packaging are still intact.Thus, the pollution must have occurred during the packaging process, 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/insufficient inspection specification.

• Brand Name: K-WIRE, STERILE T2 FEMUR Ø1,8X310 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: 7870750
• Report Number: 0009610622-2018-01046
• Device Sequence Number: 10811046
• Product Code: LXH
• UDI-Device Identifier: 04546540143488
• UDI-Public: 04546540143488
• 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,Followup
• Report Date (Section B): 10/10/2018

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: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 01520218S
• Device Lot Number: K056882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 10/10/2018
• 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