MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT SPS Ø3.2X230MM AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	700357
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "during drilling for screw insertion into the pelvis, the tip approximately 17mm long broke off and remained inside the body.The operating surgeon deemed it unproblematic and concluded the procedure with the fragment left in place.".
Event or Problem Description
As reported: "during drilling for screw insertion into the pelvis, the tip approximately 17mm long broke off and remained inside the body.The operating surgeon deemed it unproblematic and concluded the procedure with the fragment left in place.".
Additional Manufacturer Narrative
Correction: please refer to section d4 (catalog# and gtin).The reported event could be confirmed during the investigation.The device inspection revealed the following: the identification of the returned drill could be confirmed based on the catalog number and lot number marked.The instrument has fractured at its tip, the detached fragment has not been returned.The surface breakage give indication of a sudden brittle fractured, resulting from excessive bending load.Dimensional and material integrity inspection confirmed that the device and its material are within specification.Based on investigation, the root cause was attributed to an user related issue.The breakage occurred most probably as a result of excessive load.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 more information is provided, the case will be reassessed.

• Brand Name: DRILL BIT SPS Ø3.2X230MM 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23871900
• Report Number: 0008031020-2025-02209
• Device Sequence Number: 17294502
• Product Code: LXH
• UDI-Device Identifier: 04546540413796
• UDI-Public: (01)04546540413796(10)26116H
• 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): 02/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 700357
• Device Lot Number: 26116H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown