MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS IN-SITU ROD BENDER RIGHT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48560022
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/08/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; surgeon was using the in situ benders to manipulate the rod in patient and the tip broke off.No harm was done to the patient and everything was recovered.When getting the instrument back after the washers the tip had gone missing.Was lost in washer.
Additional Manufacturer Narrative
No relevant manufacturing issues were found upon device history review.Tip fracture was confirmed visually.The age of the device was found to be 13 years old.The probable root cause of the device is normal wear and tear of instruments.
Event or Problem Description
It was reported that; surgeon was using the in situ benders to manipulate the rod in patient and the tip broke off.No harm was done to the patient and everything was recovered.When getting the instrument back after the washers the tip had gone missing.Was lost in washer.

• Brand Name: OASYS IN-SITU ROD BENDER RIGHT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6681587
• Report Number: 0009617544-2017-00276
• Device Sequence Number: 992323
• Product Code: LXH
• UDI-Device Identifier: 07613327271133
• UDI-Public: (01)07613327271133
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2017

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
• Operator of Device: No Information
• Device Model Number: 48560022
• Device Catalogue Number: 48560022
• Device Lot Number: 048161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Initial Date Received by Manufacturer: 06/08/2017
• Supplement Date Received by Manufacturer: 06/08/2017
• Initial Report FDA Received Date: 06/30/2017
• Supplement Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1