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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL GRYPHON SLOTTED FISHMOUTH GDE; BONENAIL GUIDEWIRE
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MEDOS INTERNATIONAL SARL GRYPHON SLOTTED FISHMOUTH GDE; BONENAIL GUIDEWIRE Back to Search Results
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 02/23/2021
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 sales rep in (b)(6) that during a shoulder repair procedure on (b)(6) 2021, it was observed that the sleeve on the drill guide device come apart from handle.Both fragments recovered and another like device was used to complete the procedure with a delay of two minutes.There were no adverse patient consequences reported.No additional information was provided.
 
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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 Key11455346
Report Number1221934-2021-00804
Device Sequence Number16941804
Product Code LXH
UDI-Device Identifier10886705024131
UDI-Public10886705024131
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
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
Report Date (Section B) 02/24/2021
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 Number210826
Device Catalogue Number210826
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/24/2021
Initial Report FDA Received Date03/10/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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