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

Model Number	8756480
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2021
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 was received from a healthcare provider (hcp), distributor (dis) via manufacturer representative regarding spinal therapy for cervical hernia.It was reported that during cervical arthrodesis surgery, physician needed to move the surgical field further away with the distractors, where there was a snap, and it was observed that the solders of the distractor rods came loose.There was patient involved in the event and no further complications or symptoms were reported.Additional information was received via manufacturer representative that the retractors were broken and not the driver.There is no malfunction associated with the driver.The products came in contact with the patient.

• 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: 12858733
• Report Number: 1030489-2021-01441
• Device Sequence Number: 4351171
• Product Code: LXH
• UDI-Device Identifier: 00681490520126
• UDI-Public: 00681490520126
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/22/2021

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: 8756480
• Device Catalogue Number: 8756480
• Device Lot Number: PM20D001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 11/22/2021
• Date Device Manufactured: 05/28/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female