MAUDE Adverse Event Report: DEPUY MITEK LLC US FEM.INTRAFXSHEATH&SCRSYS,8.5MM; ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, STERILE

Catalog Number	254683
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/16/2017
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.The complaint device is not being returned, therefore unavailable for a physical evaluation.A review into the depuy synthes mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.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.A device history record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.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).This report is being filed from the (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported during anterior cruciate ligament the biointrafix tibial 30 mm and femoral intrafix sheath 8.5 mm broke during insertion.The procedure was completed using a like device in the same bone hole.The was no patient consequence or surgical delay.This report is 1 of 2 for (b)(4).

• Brand Name: FEM.INTRAFXSHEATH&SCRSYS,8.5MM
• Common Device Name: ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, STERILE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8290607
• Report Number: 1221934-2018-53611
• Device Sequence Number: 11378247
• Product Code: MAI
• UDI-Device Identifier: 10886705013647
• UDI-Public: 10886705013647
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2017

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 Expiration Date: 11/30/2018
• Device Catalogue Number: 254683
• Device Lot Number: 3882120
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2017
• Initial Report FDA Received Date: 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1