MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR RIGHT FEMUR 8 HOLE / L202MM; PLATE, FIXATION, BONE

Catalog Number	627638
Health Effect - Clinical Codes	Tissue Damage (2104); Device Embedded In Tissue or Plaque (3165)
Date of Event	07/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Hospital policy.
Event or Problem Description
This pi is for removal of three screws and screwdriver breakage.One screw was protruding through (i.E.Breaking) patients' skin in a plate/ screw construct.The first screw stripped and remained in patient, second screw removed without incident.The shaft of the screwdriver broke when attempting to remove the third screw.Patient's bone quality unknown.Rep reported that x-rays, medical records, and additional information are not available due to hospital policy.
Additional Manufacturer Narrative
This device is concomitant and did not contribute to the reported failure.Therefore, this complaint is closed without further investigation.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
Event or Problem Description
This pi is for removal of three screws and screwdriver breakage.One screw was protruding through (i.E.Breaking) patients' skin in a plate/ screw construct.The first screw stripped and remained in patient, second screw removed without incident.The shaft of the screwdriver broke when attempting to remove the third screw.Patient's bone quality unknown.Rep reported that x-rays, medical records, and additional information are not available due to hospital policy.

• Brand Name: DISTAL LATERAL FEMUR PLATE AXSOS 3 TI FOR RIGHT FEMUR 8 HOLE / L202MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7756194
• Report Number: 0008031020-2018-00547
• Device Sequence Number: 16415128
• Product Code: HRS
• UDI-Device Identifier: 07613252579656
• UDI-Public: 07613252579656
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K123964
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 627638
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2018
• Supplement Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 0
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 72