MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP RECIPROCATING BLADE, DOUBLE SIDED, OFFSET (70.0 X 0.64 X 12.6MM); BLADE, SAW, GENERAL & PLASTIC SURGERY,SURGICAL

Catalog Number 0277096275

Device Problem Fracture (1260)

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

Event Date 06/05/2023

Event Type  malfunction  

Manufacturer Narrative

H6: a follow up report will be filed once the quality investigation is complete.Awaiting confirmation if device is available for return.

Event Description

It was reported via medwatch mw 5118373 that the blade broke while cutting bone.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.

Event Description

It was reported via medwatch mw5118373 that the blade broke while cutting bone.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.

Manufacturer Narrative

D4: catalog number from unknown to 0277096275.H6: the quality investigation is complete.

• Brand Name: RECIPROCATING BLADE, DOUBLE SIDED, OFFSET (70.0 X 0.64 X 12.6MM)
• 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: 17331760
• MDR Text Key: 319098402
• Report Number: 3015967359-2023-01453
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0277096275
• Device Lot Number: 23045057
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: 6296000000 SN UNKNOWN