MAUDE Adverse Event Report: DEPUY MITEK RIGIDFIX FEMORAL ROD 9MM 1PK; BONENAIL GUIDEWIRE

Catalog Number	213709
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/25/2015
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.The 9mm femoral rod is fully functional with no defect.The complaint is fully attributed to the soft tissue guide thumb screw, the other product associated with this complaint, and is not to do with the femoral rod.The complaint for this product code specifically cannot be confirmed as there is nothing wrong with the product.A batch review was not conducted as the batch number is unknown.At this point in time, no corrective action is required and no further action is warranted.(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 hospital that during anterior cruciate ligament (acl) reconstruction procedure; after reaming into the femur and tibia, a 9mm aiming guide was screwed into rigidfix u-shaped guide.While tightening the bolt on the u-shaped guide to the 9mm aiming guide, the bolt broke off leaving a piece of the bolt inside the u-shaped guide causing the 9mm aiming guide to be stuck inside the u-shaped guide.-no adverse effects occurred nor any extended procedure time.Secured the aiming guide to the opposite side of the u-shaped guide with another bolt.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: RIGIDFIX FEMORAL ROD 9MM 1PK
• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7751836
• Report Number: 1221934-2018-53226
• Device Sequence Number: 1337454
• Product Code: LXH
• UDI-Device Identifier: 10886705003037
• UDI-Public: 10886705003037
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/25/2015

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: 213709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2015
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2015
• Initial Report FDA Received Date: 08/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1