MAUDE Adverse Event Report: DEPUY MITEK RESTORE FEMAIMER OFFSET 6MM *EA; MISCELLANEOUS ORTHO SURGICAL INSTRUMENT

Catalog Number	219356
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter¿s complete mailing address was not provided.Reporter¿s phone number was not provided.Reporter¿s contact name was not provided.The complaint device was received and inspected.It was observed that the tip of the device was broken.The laser lines of the device were heavily faded, indicating heavy use of the device.This complaint can be confirmed.The device is reusable.Mishandling/ dropping of the device is a common cause for sections of the device being broken.Other than this possibility, we cannot discern a root cause for this failure mode.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, 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 serial/lot number was not available.
Event or Problem Description
It was reported that during loan set inspection that the foot of the guide wire was broken on the restore femaimer offset.There was no 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.

• Common Device Name: MISCELLANEOUS ORTHO SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7952674
• Report Number: 1221934-2018-54863
• Device Sequence Number: 19177736
• Product Code: LXH
• UDI-Device Identifier: 10886705005963
• UDI-Public: 10886705005963
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: E521628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/10/2017

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: 219356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1