MAUDE Adverse Event Report: STRYKER TRAUMA KIEL GUIDE WIRE, SMOOTH-TIPPED, STERILE T2 HUMERUS Ø2,2X800 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-0093S
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/20/2018
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 in-coming inspection at distribution, it was found that there was a foreign material (hair) 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 guide wire, smooth-tipped, sterile t2 humerus ø2,2x800 mm [packaging] is stated to be the primary product.No further associated products were reported.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.The found foreign material [hair] has to be classified as a non-conformance.Ncr # (b)(4) was triggered for further root cause investigation.
Event or Problem Description
In in-coming inspection at distribution, it was found that there was a foreign material (hair) in blister.No patient involvement, adverse consequences, delay or medical intervention.

• Brand Name: GUIDE WIRE, SMOOTH-TIPPED, STERILE T2 HUMERUS Ø2,2X800 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: 7531076
• Report Number: 0009610622-2018-00209
• Device Sequence Number: 13907812
• Product Code: LXH
• UDI-Device Identifier: 04546540195975
• UDI-Public: (01)04546540195975
• 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): 07/09/2018

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: Other
• Device Expiration Date: 02/28/2023
• Device Model Number: 1806-0093S
• Device Catalogue Number: 18060093S
• Device Lot Number: K07F79D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Initial Date Received by Manufacturer: 04/23/2018
• Supplement Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 05/21/2018
• Supplement Report FDA Received Date: 07/09/2018
• 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