MAUDE Adverse Event Report: MSD BARTLETT MFG TL REVISION INSTRUMENTS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	8616001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2020
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 professional (hcp) via a medtronic representative regarding a patient implanted with a screw using a driver for correction and fixation to treat ais (adolescent idiopathic scoliosis).It was reported that correction and fixation were performed to treat ais.The nut was tightened during rod placing and correction.At that time, the tip of the driver was broken.The nut gripping part is made up of small parts, and it seems that the screw that holds it came off.It is essential to check this screw for breaking (whether there are fragments remained).The pre-op diagnosis was adolescent idiopathic scoliosis.Levels implanted were t5-t12.The sales rep has not received any contact that there were any patient symptoms or complications as a result of this event.The instrument broke and there was no fragment of the instrument remaining in the patient's body.There was no in- patient hospitalization or prolongation of existing hospitalization was necessary.No health damage in the patient was reported.The product will be replaced by a medtronic product in the future.No further complications reported/ anticipated.
Additional Manufacturer Narrative
H3: product analysis part# 8616001, lot# im07e020- visual, optical: visual and optical inspection the tongue at the tip of the nut driver has detached.The screw that holds the tongue to the driver is missing.The screw was not returned for damage analysis.Without the screw the instrument will not function correctly.Unable to determine root cause of missing screw.H6: updated patient code, eval.Code method, eval.Code result post analysis 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: TL REVISION INSTRUMENTS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MSD BARTLETT MFG; 2975 brother blvd; bartlett TN 38133
• MDR Report Key: 10395023
• Report Number: 1030489-2020-01076
• Device Sequence Number: 3552362
• Product Code: LXH
• UDI-Device Identifier: 00673978064628
• UDI-Public: 00673978064628
• 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): 01/28/2021

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: 8616001
• Device Catalogue Number: 8616001
• Device Lot Number: IM07E020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1