MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TIBIAL NAIL T2 ALPHA TIBIA 10X315MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2341-1031S
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device was implanted, only packaging is available.
Event or Problem Description
As reported: "there was a foreign material like hair between film and packaging." "the nail was used for procedure.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since only the packaging was received unpacked and no other evidence was provided [e.G.Image of packaging pollution in intact and unpacked condition].More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.The presence of the foreign material could have been best presented in original condition, which would have been possible in this case.Nothing was reported during incoming inspection at distribution site respectively during incoming inspection at the hospital itself or before surgery.The foreign material is obviously and would have been detected during inspection.However, as advised per ifu an inspection is recommended prior to surgery.It could not be excluded that the pollution occurred during storage/handling at user site.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.
Event or Problem Description
As reported: "there was a foreign material like hair between film and packaging." "the nail was used for procedure.".

• Brand Name: TIBIAL NAIL T2 ALPHA TIBIA 10X315MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 10496892
• Report Number: 0009610622-2020-00498
• Device Sequence Number: 2199123
• Product Code: HSB
• UDI-Device Identifier: 07613327291025
• UDI-Public: 07613327291025
• Combination Product (Y/N): N
• PMA/510(K) Number: K193308
• 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): 12/01/2020

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 Model Number: 2341-1031S
• Device Catalogue Number: 23411031S
• Device Lot Number: K08D110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 12/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1