MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP THIN OFFSET (9.0 X 0.38 X 31.0MM); BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number 2296003525

Device Problem Fracture (1260)

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

Event Date 09/13/2023

Event Type  Injury  

Manufacturer Narrative

H6: the quality investigation is complete.H3 other text: device not returned.

Event Description

It was reported that during the cutting of a patient¿s bone, the blade broke, this happened on three occasions, (this is for event two).It was also reported that medical intervention was required to remove the fragments of broken blade.It was further reported that the medical intervention was successful and did not cause a delay, and that the procedure was completed successfully.

• Brand Name: THIN OFFSET (9.0 X 0.38 X 31.0MM)
• 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: 17914440
• MDR Text Key: 325414882
• Report Number: 3015967359-2023-02091
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 04546540046680
• UDI-Public: 04546540046680
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2296003525
• Device Lot Number: 23209017
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2023
• 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
• Patient Outcome(s): Required Intervention