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

Model Number	210826
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).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.Udi: (b)(4).
Event or Problem Description
It was reported by the sales rep via phone that during a labral repair procedure the shaft of the gryphon slotted fishmouth guide got separated from the handle.Another device was used to complete the procedure.No patient consequences reported.5 minutes delay.The device is available to be returned for evaluation.
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 edwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: according to the information provided, it was reported by the sales rep via phone that during a labral repair procedure the shaft of the gryphon slotted fishmouth guide got separated from the handle.The complaint device was received and evaluated.Visual observations reveal that the handle assembly and the shaft were received disassembled, damages were not observed in the shaft or in the handle.In addition, the shaft still has the sharp edges.Besides, the laser impressions on the handle and on the shaft are in good condition.The complaint can be confirmed.The possible root cause for the reported failure can be attributed to the age and repeated use of the device causing fair wear and tear.However, this cannot be conclusive determined.A manufacturing record evaluation was performed for the finished device lot number 1709001, and no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
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.H6: method codes: a manufacturing record evaluation was performed for the finished device [1709001] number, and no non-conformances were identified.D10, h3, h6: 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 FISHMOUTH GDE
• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10622277
• Report Number: 1221934-2020-02854
• Device Sequence Number: 17115038
• Product Code: LXH
• UDI-Device Identifier: 10886705024131
• UDI-Public: 10886705024131
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2020

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
• Device Lot Number: 1709001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 10/05/2020; 10/11/2020
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 10/09/2020; 10/13/2020
• Patient Sequence Number: 1