MAUDE Adverse Event Report: STRYKER GMBH SPS DRILL BIT D2.5X125MM AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	UNKNOWN
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that ""left ankle fixation, used the 2.5 stryker drill bit (700347), which snapped, leaving 2cm of drill bit within the patients left medial malleolus.The surgeon was mr fergusson.The incident occurred during the primary surgery.The procedure was completed successfully.There was no surgical delay and therefore no adverse consequences due to delays.The case was completed successfully using an alternative drill bit and the incident discussed with orthopaedic colleagues on the mainland immediately at the end of the case.The final outcome was that the fracture was reduced and stabilised with good positioning of the metalwork and joint spaces.The surgeon does not anticipate any long-lasting effects as there is the additional fixation metalwork also in situ.The other implants used were stryker 8-hole 1/3 tubular plate, cortical and cancellous screws and x2 k-wires for stabilisation and then removed.I cannot be certain how long the drill bit has been in use.The tray where the drill bit has been in use as a reusable item was introduced in 2008 and that tray has been processed 117 times.We have had, up until recently 2 of the drill bits on the tray so very difficult to determine exact number of uses.The item was not part of a loan set and yes, the drill bit was inspected prior to use.The device is not available as it was disposed after the procedure".".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that ""left ankle fixation, used the 2.5 stryker drill bit (700347), which snapped, leaving 2cm of drill bit within the patients left medial malleolus.The surgeon was (b)(6).The incident occurred during the primary surgery.The procedure was completed successfully.There was no surgical delay and therefore no adverse consequences due to delays.The case was completed successfully using an alternative drill bit and the incident discussed with orthopaedic colleagues on the mainland immediately at the end of the case.The final outcome was that the fracture was reduced and stabilised with good positioning of the metalwork and joint spaces.The surgeon does not anticipate any long-lasting effects as there is the additional fixation metalwork also in situ.The other implants used were stryker 8-hole 1/3 tubular plate, cortical and cancellous screws and x2 k-wires for stabilisation and then removed.I cannot be certain how long the drill bit has been in use.The tray where the drill bit has been in use as a reusable item was introduced in 2008 and that tray has been processed 117 times.We have had, up until recently 2 of the drill bits on the tray so very difficult to determine exact number of uses.The item was not part of a loan set and yes, the drill bit was inspected prior to use.The device is not available as it was disposed after the procedure".".

• Brand Name: SPS DRILL BIT D2.5X125MM 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: 24521792
• Report Number: 0008031020-2026-00399
• Device Sequence Number: 18567943
• Product Code: LXH
• UDI-Device Identifier: 04546540368973
• UDI-Public: 04546540368973
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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 Model Number: UNKNOWN
• Device Catalogue Number: 700347
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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