MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO RECIPROCATING BLADE HEAVY DUTY LONG, OFFSET (77.6 X 0.77 X 11.2MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL.

Model Number 0277096325

Device Problem Fracture (1260)

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

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.Device discarded.

Event Description

It was reported that during a ankle replacement procedure, two blades broke at the mount.It was also reported that there were no adverse consequences as a result of this event.It was further reported that there was a delay of one to two minutes and the procedure was completed successfully.This report is for the first blade that broke.

Manufacturer Narrative

H6: the quality investigation is complete.

Event Description

It was reported that during a ankle replacement procedure, two blades broke at the mount.It was also reported that there were no adverse consequences as a result of this event.It was further reported that there was a delay of one to two minutes and the procedure was completed successfully.This report is for the first blade that broke.

• Brand Name: RECIPROCATING BLADE HEAVY DUTY LONG, OFFSET (77.6 X 0.77 X 11.2MM)
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL.
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 11059531
• MDR Text Key: 223432145
• Report Number: 0001811755-2020-03543
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 04546540051783
• UDI-Public: 04546540051783
• Combination Product (y/n): N
• PMA/PMN Number: NULL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2021

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
• Device Operator: Health Professional
• Device Model Number: 0277096325
• Device Catalogue Number: 0277096325
• Device Lot Number: 20205037
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 02/04/2021
• Supplement Dates FDA Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1