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	No Consequences Or Impact To Patient (2199)
Date of Event	02/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Device was used for treatment, not diagnosis.Investigation summary: according to the information provided, it was reported that the handle on the customer's gryphon slotted fishmouth guide was separated from the shaft.The complaint device was received and evaluated.Visual observations reveals that the handle assembly and the shaft were received disassembled, damages not were observed in the shaft or in the handle.In addition the shaft still have the sharp edges.Besides, the laser impressions on the handle and on the shaft are in good condition.Confirming this complaint.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.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.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.Udi: (b)(4).
Event or Problem Description
It was reported by the sales rep via phone that during a shoulder repair procedure the handle on the customer's gryphon slotted fishmouth guide separated from the handle.There was no debris in the patient.The procedure was completed with another like device with no patient harm or surgical delay to the case.The device will be returning for evaluation.

• 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: 9876055
• Report Number: 1221934-2020-00975
• Device Sequence Number: 3384479
• Product Code: LXH
• UDI-Device Identifier: 10886705024131
• UDI-Public: 10886705024131
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/23/2020

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: 1804001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 03/24/2020
• Patient Sequence Number: 1