MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH T.L.I.F. SG INSTRUMENTS RING CURETTE, STRAIGHT 8MM

Model Number 202711101

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/07/2021

Event Type  malfunction  

Manufacturer Narrative

Reporter is a j&j sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on (b)(6) 2021, during spinal fusion surgery the instrument broke off.The surgeon was using the instrument to remove disc and the metal tip of the handle broke.The instrument was promptly removed from the sterile field and no harm was committed.There were no fragments generated and no patient consequences.Procedure was completed successfully without any surgical delay.This report is for one (1) t.L.I.F.Sg instruments ring curette, straight 8mm.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6- the complaint condition was confirmed as the device was broken.No definitive root cause could be determined based on the provided information.The unintended forces might have contributed to the reported complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot part # 202711101 , lot # 0709hg, supplier: (b)(4).Batch # 1 qty - release to warehouse date: 27 jul 2009.Batch # 2 qty - release to warehouse date: 30 jul 2009.No ncr's were generated during production.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: T.L.I.F. SG INSTRUMENTS RING CURETTE, STRAIGHT 8MM
• Type of Device: CURETTE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11929704
• MDR Text Key: 257411345
• Report Number: 1526439-2021-01093
• Device Sequence Number: 1
• Product Code: HTF
• UDI-Device Identifier: 10705034184234
• UDI-Public: (01)10705034184234
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 202711101
• Device Catalogue Number: 202711101
• Device Lot Number: 0709HG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Date Manufacturer Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1