MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GRYPHON SLOTTED FISHMOUTH GDE; BONENAIL GUIDEWIRE

Model Number	210826
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b(4).The lot number was unknown.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 or Problem Description
It was reported by the affiliate in (b)(6) that during an orthopedic procedure on (b)(6) 2021, it was observed that the guide on the gryphon slotted fishmouth gde device disarmed when the guide was removed from the arthroscopy cannula.There were no adverse patient consequences reported.No additional information was provided.
Additional 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 mitek or its employees that the report constitutes an admission that the device, 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.H10 additional nrrative: investigation summary: according to the information provided, it was reported that during the procedure while the gryphon implant was being placed and when the guide was removed from the arthroscopy cannula the guide was disarmed.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.However the customer provided a photo of the device which is showing the shaft disassembled.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the inspection of the photo, 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 ifu108410; 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.
Additional 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 mitek or its employees that the report constitutes an admission that the device, 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.H10 additional narrative: b5: subsequent follow-up with the customer, additional information was received regarding the event.Therefore, the event description has been updated accordingly.
Event or Problem Description
It was reported by the affiliate in colombia that during an orthopedic procedure on (b)(6) 2021, it was observed that the guide on the gryphon slotted fishmouth gde device disarmed when the guide was removed from the arthroscopy cannula.The procedure was completed without delay using the blue guide that went on the instrument.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: GRYPHON SLOTTED FISHMOUTH GDE
• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 11968463
• Report Number: 1221934-2021-01807
• Device Sequence Number: 19580798
• Product Code: LXH
• UDI-Device Identifier: 10886705024131
• UDI-Public: 10886705024131
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/24/2021

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: 210826
• Device Catalogue Number: 210826
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 06/11/2021; 06/28/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 06/14/2021; 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1