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

Model Number	9560547
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding an event happened during intra-op of the reported instrument.Pre-op diagnosis of patient was lumbar disc herniation.It was reported that, the curette that was used about twice after the purchase was broken.The handle portion and shaft portion were broken from the perforated region, and the physician who used it previously seemed to have experience.At that time, it was believed that the product had deteriorated over time, but this time, the product was suspected to have had an initial defect due to its shallow usage.Procedure or technique performed was micro endoscopic discectomy.There were no patient symptoms reported, no additional treatment or surgery performed as a result, no further complications reported.
Additional Manufacturer Narrative
H3: product analysis of part # 9560547 ; lot# gz20c018 visual and optical examination identified that the shaft of the curette has broken where it meets the handle.Microscopic examination reveals the fracture appears to be the result of bend stress overload.This regulatory report is being submitted due to retrospective review through capa 624392.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: METRX
• 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: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 21236302
• Report Number: 1030489-2025-00343
• Device Sequence Number: 8967480
• Product Code: LXH
• UDI-Device Identifier: 00673978085975
• UDI-Public: 00673978085975
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/25/2025

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: 9560547
• Device Catalogue Number: 9560547
• Device Lot Number: GZ20C018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 01/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2020
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown