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U.S. Department of Health and Human Services

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.

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STRYKER INSTRUMENTS-KALAMAZOO RECIPROCATING BLADE HEAVY DUTY LONG, OFFSET (77.6 X 0.77 X 11.2MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL. Back to Search Results
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.
 
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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 Key11059531
MDR Text Key223432145
Report Number0001811755-2020-03543
Device Sequence Number1
Product Code GFA
UDI-Device Identifier04546540051783
UDI-Public04546540051783
Combination Product (y/n)N
PMA/PMN Number
NULL
Number of Events Reported1
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 Number0277096325
Device Catalogue Number0277096325
Device Lot Number20205037
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/07/2020
Initial Date FDA Received12/22/2020
Supplement Dates Manufacturer Received02/04/2021
Supplement Dates FDA Received02/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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