MAUDE Adverse Event Report: DEPUY MITEK LLC US RIGIDFIX FEM/TIB ROD THUMBSCR *EA; ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR

Catalog Number	213600
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.Further, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.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).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 sales rep via phone that during an acl reconstruction procedure the sales rep's rigidfix femoral thumb screw broke off the rigidfix frame.The sales rep did not know what caused the thumb screw to break, but breakage occurred outside of the patient cavity with no fragments created.The breakage of the thumb screw did not interrupt the case and the procedure was completed successfully with no patient harm or delay.The sales rep could not provide a lot number for the device.The device was discarded by the customer.

• Common Device Name: ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8421517
• Report Number: 1221934-2019-56619
• Device Sequence Number: 16590565
• Product Code: LXH
• UDI-Device Identifier: 10886705002634
• UDI-Public: 10886705002634
• Combination Product (Y/N): N
• 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): 02/27/2019

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: 213600
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 03/14/2019
• Patient Sequence Number: 1