MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FIXATION K-WIRE T2 TIBIA SPI Ø3X285 MM, WCH COATED; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18061417S
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/29/2016
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 fixation k-wire t2 tibia spi ø3 x 285 mm, wch coated 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 stryker (b)(4), 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.The found hair has to be classified as a non-conformance; previous actions are in place.The case is transferred to already existing ncr / capa which initiated project # (b)(4) ¿clean room¿.
Event or Problem Description
In in-coming inspection at distribution, it was found that there was a foreign material (hair) in blister.

• Brand Name: FIXATION K-WIRE T2 TIBIA SPI Ø3X285 MM, WCH COATED
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 6309113
• Report Number: 0009610622-2017-00047
• Device Sequence Number: 16288235
• Product Code: HSB
• UDI-Device Identifier: 07613252577478
• UDI-Public: (01)07613252577478(11)161117(17)211031(10)K045198
• Combination Product (Y/N): N
• PMA/510(K) Number: K131365
• 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): 02/07/2017

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: 10/31/2021
• Device Catalogue Number: 18061417S
• Device Lot Number: K045198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2017
• Initial Report FDA Received Date: 02/07/2017
• 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