MAUDE Adverse Event Report: DEPUY MITEK LLC US RESTORE TIBIAL GUIDE/RATCHET, ±10%; BONENAIL GUIDEWIRE

Catalog Number	219301
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2013
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.The complaint device was received and evaluated.There is no spring mechanism on this device.The thumbscrew holds the ratcheting rail into the guide.We cannot confirm the reported event.However, it was observed that the guide is slightly bent.The device appears old, extremely worn and laser etch has faded.The observed failure can be attributed to field wear.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.At this point in time, no further action is warranted.However, depuy 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).Depuy synthes has been informed that the lot number is not available.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 an acl repair that the spring mechanism in customer's tibial ratchet guide was broken and would not stay together.The surgeon completed the procedure by having one person holding the device together while he was drilling.The sales rep confirmed that there were no patient consequences or delay.The sales rep could not provide a lot number or age of the device but stated the device was very worn and has seen heavy use.

• Brand Name: RESTORE TIBIAL GUIDE/RATCHET, ±10%
• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7784957
• Report Number: 1221934-2018-51817
• Device Sequence Number: 136286
• Product Code: FZX
• UDI-Device Identifier: 10886705005567
• UDI-Public: 10886705005567
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 12/06/2013

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: 219301
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2013
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2013
• Initial Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1