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

Model Number	8756481
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information received from healthcare provider via manufacturer representative regarding an event happened during intra-op for a patient undergoing unknown spinal therapy.The pre-op diagnosis was mentioned as c5/c6 cervical disc lesion.It was reported that, the right distractor was set before the discectomy.When distraction was applied, one welded part of the shaft where the pin entered was broken.They changed to a left distractor and tried the same operation, but the weld part was also broken.The shaft and base were separated.The products were broken at the weld part when distraction was applied.Since both of the products were broken, they dealt with the operation without a distractor.The physician viewed that it was interfering with the retractor at the time of expanding, but due to the load applied forcefully and continuously, the load was applied in this way and the products were broken.There were no broken fragments of distractor remains in patient.The procedure was completed successfully.There was no delay in procedure reported as a result of this event.There was no additional treatment or surgery performed.No symptoms to patient reported.No further complications reported.
Additional Manufacturer Narrative
H3: product analysis of part # 8756481 ; lot # pm12m008 analysis summary: visual and optical inspection confirmed one of the distractor tubes is broken at the level of the welding.No defects were found at the level of the breakage.This type of breakage is consistent with an overloading of the welding by applying excessive distraction loads at the tip of the instrument.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TRIMLINE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 12568008
• Report Number: 1030489-2021-01235
• Device Sequence Number: 17167542
• Product Code: LXH
• UDI-Device Identifier: 00681490520133
• UDI-Public: 00681490520133
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2022

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: 8756481
• Device Catalogue Number: 8756481
• Device Lot Number: PM12M008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 04/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male