MAUDE Adverse Event Report: DEPUY MITEK LLC US RGDFIX FEM3.3MM ST BR XPIN KIT; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	210816
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).The lot number is currently unavailable; therefore, the exp date is unavailable.The complaint device is not being returned, it has been discarded by the customer therefore is unavailable for a physical evaluation.Furthermore, no lot numbers were supplied which precludes conducting a device history record review or a lot specific search in the complaints handling system.Therefore, we cannot determine what caused the user to experience the reported event; we cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.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.This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
The sales rep reported via phone that when drilling the sleeve the wings broke off the trocar on the customer's rigidfix 3mm st br cross pin kit during an anterior cruciate ligament surgical procedure.The device broke outside of the patient as the guide is used on the outside.The case was completed with another like device.There were no adverse patient consequences with a 5-minute delay.The sales rep stated the device was discarded by the customer.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: RGDFIX FEM3.3MM ST BR XPIN KIT
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8277793
• Report Number: 1221934-2018-53817
• Device Sequence Number: 1601482
• Product Code: MAI
• UDI-Device Identifier: 10886705001309
• UDI-Public: 10886705001309
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• 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): 05/30/2017

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: 210816
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2017
• Initial Report FDA Received Date: 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1