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

Model Number	210824
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	03/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).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.Udi: (b)(4).
Event or Problem Description
It was reported by affiliate via personal interaction that the gryphon slotted sawtooth gde shaft came off the handle while the surgeon was using it.No patient consequences or surgical delay reported.The device is available to be returned for evaluation.
Additional Manufacturer Narrative
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.H10 additional narrative: investigation summary = > according to the information provided, it was reported that the gryphon slotted sawtooth gde shaft came off the handle.The complaint device is not being returned by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.  since the complaint device not being returned, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device (b)(4) number, 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.Device history lot = > a manufacturing record evaluation was performed for the finished device (b)(4) number, and no non-conformances were identified.

• Brand Name: GRYPHON SLOTTED SAWTOOTH GDE
• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9886641
• Report Number: 1221934-2020-01000
• Device Sequence Number: 16780872
• Product Code: LXH
• UDI-Device Identifier: 10886705024063
• UDI-Public: 10886705024063
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2020

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: 210824
• Device Catalogue Number: 210824
• Device Lot Number: 49874820000888
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 04/08/2020
• Patient Sequence Number: 1