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

Catalog Number	210826
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	03/07/2019
Type of Reportable Event	Malfunction
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.Udi: (b)(4).Investigation summary: the complaint device was received and inspected.The complaint can be confirmed.The handle had been separated from the slotted tube.It was also observed that the laser lines of the device were heavily faded.The device is reusable, and the lot number suggests that it is 3 years old.This type of failure is typically observed after the device has been reprocessed several times over the course of many years, therefore is a potential root cause for the defect observed.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.This report is being filed as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported by the sales rep via phone that during a shoulder repair procedure, it was observed that the customer's gryphon slotted fishmouth guide broke where the handle attaches to the guide.The case was completed with another like-device with no patient harm.The sales rep stated there was a minor time delay to switch to the new device, but did not know how long.The sales rep was not present and could not provide any additional information.There was a delay in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• 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: 9128712
• Report Number: 1221934-2019-58640
• Device Sequence Number: 1748931
• Product Code: LXH
• UDI-Device Identifier: 10886705024131
• UDI-Public: 10886705024131
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/08/2019

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 Catalogue Number: 210826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1