MAUDE Adverse Event Report: STRYKER SPINE-US RADIUS SHARP PROBE CURVED; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	486619035
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the distal end of pedicle probe broken off in patient bone.This occurred in the s1 vertebral body while surgeon was preparing the bone for pedicle screw placement.There are no reports of adverse health consequences to the patient.
Event or Problem Description
It was reported that the distal end of pedicle probe broken off in patient bone.This occurred in the s1 vertebral body while surgeon was preparing the bone for pedicle screw placement.There are no reports of adverse health consequences to the patient.
Additional Manufacturer Narrative
The reported event was confirmed via correspondence with the sales representative, as well as visual inspection of the returned device.The event resulted in neither surgical delay nor adverse consequence to the patient.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The most likely cause of the reported event was determined to relate to: (1) hard bone quality at the s1 level; (2) previously damaged/deformed probe after long-term usage (about 7 years); (3) difficult angle at l5/s1 with spondylolisthesis; (4) excessive forces applied.

• Brand Name: RADIUS SHARP PROBE CURVED
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7558620
• Report Number: 0009617544-2018-00116
• Device Sequence Number: 19151810
• Product Code: LXH
• UDI-Device Identifier: 07613327275780
• UDI-Public: (01)07613327275780
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2018

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: 486619035
• Device Catalogue Number: 486619035
• Device Lot Number: 111411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Initial Date Received by Manufacturer: 05/07/2018
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 05/31/2018
• Supplement Report FDA Received Date: 08/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 110