MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP RECIPROCATING BLADE, DOUBLE SIDED, OFFSET (70.0 X 1.27 X 12.5MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Model Number 0277096281

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2021

Event Type  malfunction  

Manufacturer Narrative

The quality investigation is complete.

Event Description

It was reported that during a total knee arthroplasty procedure, the blade broke at the mount.It was also reported that there was a five to ten minute delay as a result of this event.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.

• Brand Name: RECIPROCATING BLADE, DOUBLE SIDED, OFFSET (70.0 X 1.27 X 12.5MM)
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 13056247
• MDR Text Key: 282604206
• Report Number: 3015967359-2021-02763
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 04546540880789
• UDI-Public: 04546540880789
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0277096281
• Device Catalogue Number: 0277096281
• Device Lot Number: 21126017
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1