MAUDE Adverse Event Report: STRYKER GMBH STANDARD DRILL BIT EASYCLIP Ø2.0MM, AO; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	XFO012002
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: achilles tendon lengthening left foot.Triple arthrodesis with internal fixation left foot.The tip of a 2mm drill bit inadvertently broke off and "appeared to be imbedded in the area of the sinus tarsi" of the left foot during a part of the procedure where "aggressive drilling of the bone" to stimulate cartilage repair was performed.Surgeon attempted to remove it, however "decided to leave it in place due to its's benign position".Surgeon indicated he would disclose this to the patient.There was no malfunction of drill.Fda safety report id # mw5111089.
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.

• Brand Name: STANDARD DRILL BIT EASYCLIP Ø2.0MM, AO
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15325215
• Report Number: 0008031020-2022-00418
• Device Sequence Number: 6485342
• Product Code: HWE
• UDI-Device Identifier: 07613252265320
• UDI-Public: 07613252265320
• 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: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: XFO012002
• Device Catalogue Number: XFO012002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown