MAUDE Adverse Event Report: DEPUY MITEK SKID ROD W/HANDLE 2/0-0 SUTURE EA; BONENAIL GUIDEWIRE

Catalog Number	214502
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate evaluation statement: the complaint device was received and evaluated.Visual observation reveals that the proximal end of the device is separated from the shaft, confirming the complaint.This device is reusable and this failure is typically observed due to heavy usage over a period of time.Visually, the device looks worn and the laser markings are slightly faded indicating they are old and heavily used.This complaint can be confirmed.The failure can be attributed to normal field wear.Furthermore, no lot number was supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.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.(b)(4) - incomplete.The lot number is currently unavailable.This report is being filed from the remetrex complaint management system 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 that during a shoulder repair surgical procedure, it was observed that the backend of the customer's skid rod with handle 2/0-0 suture (knot pusher) that was welded together came apart.The sales rep stated that the device did not come apart in the patient.The sales rep reported that the surgeon completed the procedure with another like device with no patient consequences or delays.The sales rep could not provide a lot number for the device but stated that the device is a couple months old and used once or twice.The sales rep was not present for the case therefore could not provide any further information.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: SKID ROD W/HANDLE 2/0-0 SUTURE EA
• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7792885
• Report Number: 1221934-2018-54040
• Device Sequence Number: 16423217
• Product Code: LXH
• UDI-Device Identifier: 10886705003686
• UDI-Public: 10886705003686
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2015

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: 214502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2015
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2015
• Initial Report FDA Received Date: 08/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1