MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC TL REVISION INSTRUMENTS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	8880009
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Country: (b)(6).Pma/510(k)#: class i exempt.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
Information was received from a healthcare provider via manufacturer representative regarding a patient with an indication of vertebral canal stenosis at l5/s in need of l5/s tlif used in spinal therapy.It was reported that when retightening set screw with a driver that combined the 815-518 shaft t25 and the 8880009 so47 torque limiting driver, the tip of the broke during retightening of the non-break set screw of solera 4.75.The broken tip was removed from the surgical field. the event was thought to have occurred in the 4th one of fixation of one intervertebral disc.There were no patient symptoms reported.There were no fragments in the patient reported.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
Device evaluation summary: product analysis # (b)(4): part #: 8880009, lot # bm13a012.Visual inspection did not reveal any damage to the instrument.Functional inspection confirmed the torque limiting driver was able attach and release a sample driver but did no pass the torque test.The instrument was out of range.It appears the torque mechanism is worn from repeated use.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: TL REVISION 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: 11789027
• Report Number: 1030489-2021-00582
• Device Sequence Number: 11766511
• Product Code: LXH
• UDI-Device Identifier: 00885074226552
• UDI-Public: 00885074226552
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2021

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: 8880009
• Device Catalogue Number: 8880009
• Device Lot Number: BM13A012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 05/07/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1