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

Device Problem Vibration (1674)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/04/2020

Event Type  Injury  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.Awaiting device return.

Event 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.

Manufacturer Narrative

H6: the quality investigation is complete.H3 other text : device discarded.

Event 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
• Type of Device: 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
• MDR Text Key: 222278820
• Report Number: 0001811755-2020-03473
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07613327303759
• UDI-Public: 07613327303759
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 5108-127-070
• Device Catalogue Number: 5108127070
• Device Lot Number: 20150017
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 02/15/2021
• Supplement Dates FDA Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN SAW
• Patient Outcome(s): Required Intervention