MAUDE Adverse Event Report: STRYKER TRAUMA KIEL NAIL HANDLE T2 TIBIA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18061002
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2018
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
During a routine inspection of hospital's inventory, one of the two prongs on the tibial nail holding arm that keep the arm from rotating was found to be broken off.No associated procedure.
Event or Problem Description
During a routine inspection of hospital's inventory, one of the two prongs on the tibial nail holding arm that keep the arm from rotating was found to be broken off.No associated procedure.
Additional Manufacturer Narrative
The reported event that 1 nail handle t2 tibia was alleged of issue broken instrument could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.The product shows signs of extensive usage.One of the two prongs on the tibial nail holding arm that keep the arm from rotating has been visually confirmed to be broken off.The appearance/structure of the breakage surface and the course of the breakage line suggest that the returned product broke in a brittle forced fracture due to bending overload.Thus, based on the product inspection the root cause can be attributed to a user related issue.Stryker devices are inspected before being released for distribution, thus, we can exclude any indications of material, manufacturing or design related problems within the product.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that if any further information is provided, the complaint report will be updated.

• Brand Name: NAIL HANDLE T2 TIBIA
• 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: 8210633
• Report Number: 0009610622-2019-00003
• Device Sequence Number: 18882642
• Product Code: LXH
• UDI-Device Identifier: 04546540196538
• UDI-Public: 04546540196538
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 02/21/2019

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 Catalogue Number: 18061002
• Device Lot Number: KHI164748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 02/21/2019
• 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