MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC REVERSE BAYONETED CURETTE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	9569631
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient was pre-operatively diagnosed with lumbar radiculopathy and herniated disc.During surgery.The tip of the instrument broke off.The product came in contact with the patient.No fragments of the device are remaining in the patient.There were no patient complications as a result of event.
Additional Manufacturer Narrative
Product analysis result: visual optical visual inspection of the instrument confirmed the tip of the curette has been broken off.Microscopic examination of the fracture surface revealed a rough rigid surface.This type of damage is consistent with bend stress overload.If information is provided in the future, a supplemental report will be issued.

• Brand Name: REVERSE BAYONETED CURETTE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 8266108
• Report Number: 1030489-2019-00079
• Device Sequence Number: 19364723
• Product Code: LXH
• UDI-Device Identifier: 00885074456560
• UDI-Public: 00885074456560
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2019

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 Catalogue Number: 9569631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Initial Date Received by Manufacturer: 12/28/2018
• Supplement Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 61