MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC SALVATION DRILL BIT 4.5MM TAPERED; BIT, SURGICAL

Catalog Number	SB080045
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Event or Problem Description
It was reported that while drilling using the 4.3/3mm taper drill for a 5mm bolt the drill tip snapped on the tapered area within the patient.The drill bit was removed and the surgery continued as planned successfully.An additional dorsal incision and cut needed to be created.A surgical delay of 20 minutes was reported.
Additional Manufacturer Narrative
Correction to d9 (product available to stryker) and h6(device code ) to remove 'break' code.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.An x-ray image was provided that does appear to show a tip of some driver inside the patient.However, no assessment can be made based on the image alone.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.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that while drilling using the 4.3/3mm taper drill for a 5mm bolt the drill tip snapped on the tapered area within the patient.The drill bit was removed and the surgery continued as planned successfully.An additional dorsal incision and cut needed to be created.A surgical delay of 20 minutes was reported.

• Brand Name: SALVATION DRILL BIT 4.5MM TAPERED
• Common Device Name: BIT, SURGICAL
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22820453
• Report Number: 3010667733-2025-00949
• Device Sequence Number: 19974561
• Product Code: GFG
• UDI-Device Identifier: 00889797060585
• UDI-Public: 00889797060585
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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: SB080045
• Device Lot Number: 2112536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown