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 Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	04/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while preparing the right l4, the pedicle finder tip broke off.The tip was retrieved using a clamp from a screw removal set.There was a 20 minute surgical delay.There are no reports of adverse consequences to the patient.
Additional Manufacturer Narrative
The reported event of device tip fracture was confirmed via visual inspection.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: the most likely cause of the reported event was determined to relate to : hard bone quality; previously damaged/deformed probe after long-term usage (about 9 years); excessive forces applied.
Event or Problem Description
It was reported that while preparing the right l4, the pedicle finder tip broke off.The tip was retrieved using a clamp from a screw removal set.There was a 20 minute surgical delay.There are no reports of adverse consequences to the patient.

• 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: 7479076
• Report Number: 0009617544-2018-00098
• Device Sequence Number: 16542321
• Product Code: LXH
• UDI-Device Identifier: 07613327275780
• UDI-Public: (01)07613327275780
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/20/2018

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: Health Professional
• Device Model Number: 486619035
• Device Catalogue Number: 486619035
• Device Lot Number: 09C290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Initial Date Received by Manufacturer: 04/12/2018
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 08/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 113