MAUDE Adverse Event Report: STRYKER GMBH TWIST DRILL, DIAM.1.4X87MM, WL 27MM, AO SHAFT END, STERILE PACKED; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	91-14326
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3: tip remains in patient, the rest was discarded.
Event or Problem Description
As reported: "while drilling to insert a screw, the tip of the drill broke off and remained in the patient bone.".
Additional Manufacturer Narrative
Please note the correction to d9/h3 as the device was returned for evaluation.Please also note the correction to h6 method code.The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the visual inspection of the received drill revealed it to be broken from the tip region.The fracture surface showed edges to be deformed plastically.The cutting edges appeared to be blunt and slightly deformed.The fracture surface indicates the breakage to be due to a combination of bending and torsional overload.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation, the root cause was attributed to a user related issue.The failure was caused by application of torsional and bending load during usage.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "while drilling to insert a screw, the tip of the drill broke off and remained in the patient bone.".

• Brand Name: TWIST DRILL, DIAM.1.4X87MM, WL 27MM, AO SHAFT END, STERILE PACKED
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17224594
• Report Number: 0008031020-2023-00249
• Device Sequence Number: 7097952
• Product Code: HBE
• UDI-Device Identifier: 04546540504173
• UDI-Public: 04546540504173
• 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): 08/31/2023

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: 91-14326
• Device Catalogue Number: 91-14326
• Device Lot Number: AK09
• 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: 06/05/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2020
• 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 Sex: Unknown