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

Model Number	9569566
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
510(k) is exempt.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 a manufacturer representative regarding a patient with pre-operative diagnosis of herniated disc l3 and l4.It was reported that the pituitary break.There were no complications associated with this event.Procedure used is microdissectomy.During a herniated disc procedure, the tip of the forceps broke.Fragment remained inside the disc.It was not possible to remove the fragment.
Additional Manufacturer Narrative
Product analysis: optical examination identified that the lower arm is sheared at the locking pin and the lower jaw is missing.The location and amount of force required in order to induce fracture of the shaft is consistent with overload.H6: fdm and fdr codes updated as per new information.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: METRX
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 10498895
• Report Number: 1030489-2020-01199
• Device Sequence Number: 2961519
• Product Code: LXH
• UDI-Device Identifier: 00885074451213
• UDI-Public: 00885074451213
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: SEE H10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9569566
• Device Catalogue Number: 9569566
• Device Lot Number: GZ18A013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 09/07/2020
• Supplement Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other