MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. SALVATION; BIT, SURGICAL

Model Number	SB080045
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the step drill bit broke off in the patient's metatarsal.It snapped at the site where the step of the drill is.Located.There was a 20 minute delay to the surgery as the surgeon made a small incision posterior near the achilles to retrieve the drill bit piece.All fragments were removed.
Event or Problem Description
It was reported that the step drill bit broke off in the patient's metatarsal.It snapped at the site where the step of the drill is.Located.There was a 20 minute delay to the surgery as the surgeon made a small incision posterior near the achilles to retrieve the drill bit piece.All fragments were removed.
Additional Manufacturer Narrative
The reported event could be confirmed, since images were provided.Inspection of the provided images confirms the tip of the drill is deformed and has fractured.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.The ifu instructs the user that: "inspect devices prior to use for damage during shipment or storage or any out-of-box defects that might increase the likelihood of fragmentation during a procedure" and "surgical instruments and instrument cases are susceptible to damage from prolonged use, and through misuse or rough handling¿.The package insert also provides the following recommendation relating to device fragments, "carefully consider and discuss with the patient (if possible) the risks and benefits of retrieving vs.Leaving the fragment in the patient.¿ 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.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.

• Brand Name: SALVATION
• Common Device Name: BIT, SURGICAL
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• MDR Report Key: 11873481
• Report Number: 0001043534-2021-00088
• Device Sequence Number: 3560225
• Product Code: GFG
• UDI-Device Identifier: 00889797060585
• UDI-Public: 00889797060585
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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: SB080045
• Device Catalogue Number: SB080045
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR