MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP STRYKER-OSC 8.0X1.27X70MM; INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	5108-127-070
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting device return.
Event or Problem Description
It was reported that during a total ankle replacement procedure, while the surgeon was making a cut, the blade moved from side to side more than normal in the handpiece saw.It was also reported that the fibula was accidently fractured.It was further reported that the surgeon fixed the fracture with a cannulated screw and a plate.It was further reported that there was a 45 minute delay as a result of this event and the procedure was completed successfully.
Additional Manufacturer Narrative
H6: the quality investigation is complete.H3 other text : device discarded.
Event or Problem Description
It was reported that during a total ankle replacement procedure, while the surgeon was making a cut, the blade moved from side to side more than normal in the handpiece saw.It was also reported that the fibula was accidentally fractured.It was further reported that the surgeon fixed the fracture with a cannulated screw and a plate.It was further reported that there was a 45 minute delay as a result of this event and the procedure was completed successfully.

• Brand Name: STRYKER-OSC 8.0X1.27X70MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPAEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 11031916
• Report Number: 0001811755-2020-03473
• Device Sequence Number: 16459902
• Product Code: HWE
• UDI-Device Identifier: 07613327303759
• UDI-Public: 07613327303759
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• 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): 02/19/2021

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 Expiration Date: 05/01/2025
• Device Model Number: 5108-127-070
• Device Catalogue Number: 5108127070
• Device Lot Number: 20150017
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SAW
• Outcome Attributed to Adverse Event: Required Intervention