MAUDE Adverse Event Report: STRYKER TRAUMA KIEL GUIDE WIRE, BALL-TIPPED, STERILE T2 TIBIA Ø3X800 MM; INSTRUMENT

Catalog Number	18060080S
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2016
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 center, it was found that there was a foreign material (fiber) in package.
Additional Manufacturer Narrative
Product inquiry states the guide wire, ball-tipped, sterile t2 tibia ø3x800 mm to be the subject product.No further associated products were reported.A review of the dhr revealed no discrepancies.The reported event was confirmed.All seals and original packaging are still intact.Thus, the pollution must have occurred during the packaging process at stryker kiel, 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.The found black fibre accumulations have to be classified as a non-conformance.For a former similar case ncr had been initiated.This ncr resulted in capa, which is still under implementation.Review of complaint history and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated the issue was addressed adequately.There are further open actions in place related to the reported event for the subject product in connection with capa.
Event or Problem Description
In in-coming inspection at distribution center it was found that there was a foreign material (fiber) in package.
Additional Manufacturer Narrative
Product inquiry states the guide wire, ball-tipped, sterile t2 tibia ø3x800 mm to be the subject product.No further associated products were reported.A review of the dhr revealed no discrepancies.The reported event was confirmed.All seals and original packaging are still intact.Thus, the pollution must have occurred during the packaging process at stryker kiel, 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.The found black fibre accumulations have to be classified as a non-conformance.For a former similar case ncr had been initiated.This ncr resulted in capa, which is still under implementation.Review of complaint history and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated the issue was addressed adequately.There are further open actions in place related to the reported event for the subject product in connection with capa.
Event or Problem Description
In in-coming inspection at distribution center it was found that there was a foreign material (fiber) in package.

• Brand Name: GUIDE WIRE, BALL-TIPPED, STERILE T2 TIBIA Ø3X800 MM
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6175909
• Report Number: 0009610622-2016-00614
• Device Sequence Number: 10986371
• Product Code: LPH
• UDI-Device Identifier: 04546540195890
• UDI-Public: (01)04546540195890(11)160715(17)210630(10)K0911F9
• Combination Product (Y/N): N
• PMA/510(K) Number: K153345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2017

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: 06/30/2021
• Device Catalogue Number: 18060080S
• Device Lot Number: K0911F9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2016
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2016
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 12/15/2016
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown