MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GRYPHON SLOTTED SAWTOOTH GUIDE; BONENAIL GUIDEWIRE

Model Number 210824

Device Problem Break (1069)

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

Event Date 10/14/2022

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Reporter is a j&j sales representative.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported by the sales rep via phone that during an unknown procedure, the gryphon slotted sawtooth guide device broke in half.Another like device was used to complete the procedure.No patient consequences or surgical delay reported.No additional information was provided.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the device was received and evaluated, on visual inspection, it could be observed that the shaft is separated from the handle due to welding detachment.A manufacturing record evaluation was performed for the finished device 1312002, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection, this complaint can be confirmed.The possible root cause can be attributed to the rough and continuous use of the device.Since this is a reusable device, the constant manipulation between surgeries and sterilization process can lead to damages to the instrument.As per ifu: end of useful instrument life is generally determined by wear or damage from handling or surgical use.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: GRYPHON SLOTTED SAWTOOTH GUIDE
• Type of Device: BONENAIL GUIDEWIRE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 15700987
• MDR Text Key: 306892126
• Report Number: 1221934-2022-03354
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705024063
• UDI-Public: 10886705024063
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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
• Device Operator: Health Professional
• Device Model Number: 210824
• Device Catalogue Number: 210824
• Device Lot Number: 1312002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2022
• Initial Date FDA Received: 10/31/2022
• Supplement Dates Manufacturer Received: 11/03/2022; 11/20/2022
• Supplement Dates FDA Received: 11/04/2022; 11/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1