MAUDE Adverse Event Report: STRYKER GMBH DRILL BIT SPS Ø2.5X125MM AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	700347
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/29/2025
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: "when the product in question was used for drilling to place exeter mesh on the acetabular side for revision of another company's tha, the drill broke off due to interference with another screw.About 1.5 cm of the tip was left behind in the body.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged issue.The device inspection revealed the following: the received drill was found to be broken very close to the point from where the cutting edge starts.The tip of the drill could not be returned for evaluation as it was left inside the patient.The nature of breakage indicates predominantly towards a brittle failure evident by smooth surface in most of the fracture surface.The remaining portion of the cutting edges appears to be damaged & blunt which most likely required application of excessive bending & axial load, to appreciate the cortex ultimately leading to its breakage.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance to 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.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 above investigation, the root cause of the issue is deemed to be user related.The nature of breakage indicates towards application of excessive bending and axial loading which most likely is a result of usage of a relatively blunt drill, but not limited up to it.The ifu clearly warns the user that: while rare, intra-operative breakage of instruments can occur.Instruments which have experienced excessive use or excessive force are susceptible to breakage.The instructions cleaning, sterilization, inspection & maintenance instructs the user that: stryker t&e does not typically specify the maximum number of uses for reusable medical devices.The useful life of these devices depends on many factors including the method and duration of each use, and the handling between uses.Careful inspection and functional test of the device before use is the best method of determining the end of serviceable life for the medical device.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "when the product in question was used for drilling to place exeter mesh on the acetabular side for revision of another company's tha, the drill broke off due to interference with another screw.About 1.5 cm of the tip was left behind in the body.".

• Brand Name: DRILL BIT SPS Ø2.5X125MM 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: 22877646
• Report Number: 0008031020-2025-01412
• Device Sequence Number: 5687924
• Product Code: LXH
• UDI-Device Identifier: 04546540368973
• UDI-Public: 04546540368973
• 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): 11/24/2025

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: 700347
• Device Lot Number: H06773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2004
• 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