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

Catalog Number	210824
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Reporter is company representative.Investigation summary: the complaint device was received and inspected.It is observed that the weld is broken between the handle and shaft; causing the shaft to separate from the handle.This complaint can be confirmed.It is possible that this failure occurred during sterilization or that the device was dropped on hard surface causing the weld to fail.Other than this possibility, we cannot discern a root cause for this failure mode.The potential cause for this issue is not related to manufacturing, therefore a manufacturing record evaluation is not required.There is no lot number available to perform batch review.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.Udi: (b)(4).Lot number is unknown.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 that the gryphon slotted sawtooth guide broke at the handle and shaft when the surgeon tried to implant the anchor into the patient's body during the surgery.Breakage occurred outside the patient's body.The surgery was completed by using alternative anchor, the product code and lot number were unknown.It was brand new and the first use when the issue occurred.There was no information of surgical delay and no harm to the patient.No further information was provided by the hospital.

• 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: 9125346
• Report Number: 1221934-2019-58609
• Device Sequence Number: 16725195
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2019

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: 210824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 09/26/2019
• Patient Sequence Number: 1