MAUDE Adverse Event Report: STRYKER GMBH SCALED DRILL Ø2.5MM, AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	703966
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
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
As reported: "drilling was performed using the usual technique.Image check before screw insertion revealed that the drill tip remained in the body.The broken drill tip was safely removed and the surgery was completed successfully.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned, and matches the alleged failure.The received scaled drill was visually inspected; we can see that the breakage happened at the proximal end of the drill.The breakage surface indicates a brittle fracture.The nature of the breakage of the drill indicates towards application of bending overload during drilling we can also see slight deformation along the cutting flutes furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance with the values in the material specification.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.Based on the investigation, the root cause was user-related as the breakage was caused by excessive bending and axial overload.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "drilling was performed using the usual technique.Image check before screw insertion revealed that the drill tip remained in the body.The broken drill tip was safely removed and the surgery was completed successfully.".

• Brand Name: SCALED DRILL Ø2.5MM, AO FITTING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19264351
• Report Number: 0008031020-2024-00214
• Device Sequence Number: 6492862
• Product Code: LXH
• UDI-Device Identifier: 07613252719861
• UDI-Public: 07613252719861
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2024

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: 703966
• Device Lot Number: KU116932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/16/2024
• Supplement Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male