MAUDE Adverse Event Report: STRYKER TRAUMA KIEL GUIDE WIRE, BALL-TIPPED T2 TIBIA 3X800 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-0080
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "while the surgeon performs the initial drilling for the tibial t2 clavop, the olive guide is split, in its proximal portion, which can be removed with a rochester forceps, without any other novelty.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed: the received guide wire was found to be broken from around two-third of its length.The two broken segments were found to be bent as well.Breakage surface was visually inspected under a microscope which revealed that the breakage was ductile in nature.Severe deformation and dents were visible near the breakage point.Scratches were also found over the surface of guide wire close to the breakage point.All these signs indicate that the guide wire was sheared off during reaming.The bend, as observed in the wire, leads to increase in friction between the guide wire and reamer, which ultimately leads to material deterioration and an ultimate failure.The batch record could not be reviewed because the lot number was abraded on the returned device and the lot number was not communicated otherwise.A review of the labeling did not indicate any abnormalities.Based on investigation, the root cause was attributed to a user related issue.The breakage most likely happened due to an improper insertion of the guide wire and a subsequent intra-operative interaction of it with the reamer during the reaming process.Careful handling during reaming is recommended to avoid instrument damages.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "while the surgeon performs the initial drilling for the tibial t2 clavop, the olive guide is split, in its proximal portion, which can be removed with a rochester forceps, without any other novelty.".

• Brand Name: GUIDE WIRE, BALL-TIPPED T2 TIBIA 3X800 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 11382465
• Report Number: 0009610622-2021-00312
• Device Sequence Number: 19864888
• Product Code: LXH
• UDI-Device Identifier: 04546540195883
• UDI-Public: 04546540195883
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2021

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: 1806-0080
• Device Catalogue Number: 18060080
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 63