MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC NON-THREADED INSTRUMENTS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	2900163
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: visual and optical examination identified that the tip of the instrument has cracked down near the shaft.The cutting edge of the blade is dulled from what appears to be repeated use.This dulling could have led to more pressure being needed till the material was overloaded and broke.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a health care provider via a manufacturer representative regarding a patient with stenosis for plif.It was reported that intra-operatively, ring curette was broken.There was no fragments of the implant or instrument remaining in the patient.There were no patient symptoms or complications as a result of this event.There was no treatment or additional surgery performed as a result of this event.The product came in contact with patient but there was no harm to the patient.

• Brand Name: NON-THREADED INSTRUMENTS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 10902861
• Report Number: 1030489-2020-01692
• Device Sequence Number: 19166576
• Product Code: LXH
• UDI-Device Identifier: 00885074038308
• UDI-Public: 00885074038308
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 11/25/2020

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: 2900163
• Device Catalogue Number: 2900163
• Device Lot Number: IM15L025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1