MAUDE Adverse Event Report: STRYKER GMBH TEMP. PLATE FIXATOR PIN AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	705019-1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/22/2020
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: "during the orif for the femur, when other company nail was inserted, the fixator was drilled, and the tip of the drill was broke and remained inside the patient's body.The broken tip of the drill was remained inside the patient body with the surgeon's judgement and the operation was completed.".
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the device is broken at the level of the threaded part.A microscope analysis shows plastic deformation on the outskirts of the broken surface as well as rest lines in the center of the broken surface.Typically, fractures due to normal wear of the device start with plastic deformations on the surface of the device (represented by the plastic deformations), which generate cracks that propagate (through the rest lines) in the material before breaking completely.This case is an example of such a fracture.Based on investigation, the root cause was attributed to be wear related.The failure was caused by normal wear of the device combined with a relatively high force applied.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.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
Event or Problem Description
As reported: "during the orif for the femur, when other company nail was inserted, the fixator was drilled, and the tip of the drill was broke and remained inside the patient's body.The broken tip of the drill was remained inside the patient body with the surgeon's judgement and the operation was completed.".

• Brand Name: TEMP. PLATE FIXATOR PIN AO FITTING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 10286395
• Report Number: 0008031020-2020-01919
• Device Sequence Number: 13581950
• Product Code: LXH
• UDI-Device Identifier: 07613327093407
• UDI-Public: 07613327093407
• 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): 09/02/2020

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: 705019-1
• Device Catalogue Number: 705019-1
• Device Lot Number: 00756V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2020
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 09/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1