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

Model Number	210824
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mitek employee.Investigation summary: the complaint device was received and inspected.It was observed that the handle and the shaft of the device had been separated.This complaint can be confirmed.The device is reusable.A visual inspection revealed that the device had been heavily used as distal tip of the shaft has several nicks and a burr on the side.The visual inspection also revealed small indentations on the shaft slot nearest to the connection point to the handle.The broken weld failure could be due to the device being dropped/ mishandled on hard surface causing the weld to fail.The compliant information says that the device broke during cleaning after the surgery.The lot number indicates that the device is almost six years old.Other than the possibility of mishandling, we cannot discern a root cause for this failure mode.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 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 sales rep via cst that following an unknown procedure the gryphon slotted sawtooth guide broke while cleaning during spd.It¿s broke where the guide attaches to the handle.There was no patient harm.This is report 1 for 1 (b)(4).

• Brand Name: GRYPHON SLOTTED SAWTOOTH GDE
• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9125165
• Report Number: 1221934-2019-58598
• Device Sequence Number: 11397409
• Product Code: LXH
• UDI-Device Identifier: 10886705024063
• UDI-Public: (01)10886705024063
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2019

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: 210824
• Device Catalogue Number: 210824
• Device Lot Number: 1311002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2019
• 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