MAUDE Adverse Event Report: DEPUY MITEK LLC US GRYPHON SLOTTED FISHMOUTH GDE; BONENAIL GUIDEWIRE

Model Number	210826
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mitek employee.Investigation summary.The complaint device was received and inspected.The complaint can be confirmed.It was observed that the slotted shaft and handle had been separated from one another at the weld point.The device is reusable, and the lot number suggests that the device is 5 years old.This type of failure is typically observed when the device has been reprocessed many times over the course of many years which can weaken the weld point and can lead to the separation of the slotted shaft and the handle.However, given the information provided we cannot discern a definitive root cause for the reported failure.At this point, 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 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.
Event or Problem Description
It was reported by the affiliate via email that a loan kit technician discovered that the slotted shaft was broken away from the handle during a loan kit inspection.The device has been forwarded to depuy engineering for assessment.The affiliate reports that no patient information is available.This is report 1 for 1 (b)(4).

• Brand Name: GRYPHON SLOTTED FISHMOUTH GDE
• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9124791
• Report Number: 1221934-2019-58585
• Device Sequence Number: 14157952
• Product Code: LXH
• UDI-Device Identifier: 10886705024131
• UDI-Public: (01)10886705024131
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/26/2019

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: 1412001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2019
• Initial Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1