MAUDE Adverse Event Report: STRYKER GMBH DRILL, AO, STERILE T2 FEMUR Ø4,2X340 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18064260S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
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
The drill broke whilst drilling the posterior screw on the calcaneus.A replacement was available.
Event or Problem Description
The drill broke whilst drilling the posterior screw on the calcaneus.A replacement was available.
Additional Manufacturer Narrative
Please note correction to h6 (component code).The reported event could be confirmed, since physical evaluation revealed a broken off tip.The drilling spiral of the drill returned is completely sheared off.The broken off piece was not returned.According to the appearance of the breakage surface, the drill broke in a (forced) brittle manner due to overload, most likely by bending stresses.The breakage may be caused by drilling under misalignment and / or contact with a hard object.Based on the above facts the root cause of the reported event is not related to a deficiency of the device but is rather linked to improper handling by the user.The brochure ¿instructions for cleaning, sterilization, inspection and maintenance¿ help to determine whether an instrument is in good condition or must be replaced due to excessive wear or obvious defects.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.According to event description it was stated that a ¿replacement was available¿ and per event details available the procedure was completed successfully with no impact to the patient.In addition, the risk has been evaluated and is adequately covered in the current valid risk file.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.

• Brand Name: DRILL, AO, STERILE T2 FEMUR Ø4,2X340 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18425488
• Report Number: 0009610622-2024-00001
• Device Sequence Number: 7743665
• Product Code: LXH
• UDI-Device Identifier: 04546540196774
• UDI-Public: 04546540196774
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2024

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: 18064260S
• Device Lot Number: KU167974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Male