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	09/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device was received and inspected.Visual observation indicates the thumbscrew was broken confirming this complaint.It is possible that the screw was excessively tightened on the guide frame causing fatigue and eventually breaking it.The device appears to be old and worn and thus it is also a possibility that this failure was a result of worn components.A definitive root cause could not be determined.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 corrective action is required, and no further action is warranted.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.(b)(4)-incomplete.Associated medwatch: 1221934-2018-55391.
Event or Problem Description
It was reported by the sales rep via phone that during an acl reconstruction procedure the customer's rigidfix femoral rod 7mm, rigidfix femoral rod 8mm, rigidfix femoral rod 9mm, and rigidfix femoral rod 10mm had faded laser lines, which caused issues reading the lettering on the devices.The customer's first rigidfix femoral/tibial rod thumb screw was malleted into the guide when it broke in the guide.The breakage happened outside the patient and there were no fragments in the patient.The customer's second rigidfix femoral/tibial rod thumb screw bent where the screw meets the thumb head.The screw bent while inserting into the guide.The customer's ratchet handle with jacob's chuck would not hold the driver.The case was completed using the rigidfix femoral rod 10mm, the second rigidfix femoral/tibial rod thumb screw, and an alternative fixed handle driver.The sales rep stated that there was no patient harm or delays.The sales rep could not provide lot numbers for any of the devices.The devices are being returned for evaluation.

• Common Device Name: ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8104598
• Report Number: 1221934-2018-55390
• Device Sequence Number: 1733825
• Product Code: LXH
• UDI-Device Identifier: 10886705002634
• UDI-Public: 10886705002634
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 09/28/2018

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 11/26/2018
• Patient Sequence Number: 1