MAUDE Adverse Event Report: DEPUY MITEK LLC US INTRAFIX TIBIALSHEATH 30MM *EA; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	254601
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint device was received and evaluated.Visual observations reveal that the sheath has considerable amount of bio debris on it.No structural damage was observed.There was no issue reported with the sheath in this complaint.Hence no further investigation is required.(b)(4).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 sales rep that during an acl procedure that the customer's intrafix peek tapered screw would not advance after about half way of being inserted.The screw started spinning, so the surgeon backed out both the sheath and screw and used another sheath and smaller screw to complete the procedure.There were no patient consequences.

• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7689937
• Report Number: 1221934-2018-51043
• Device Sequence Number: 2580874
• Product Code: MAI
• UDI-Device Identifier: 10886705013074
• UDI-Public: 10886705013074
• Combination Product (Y/N): N
• 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): 06/19/2013

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: 04/30/2016
• Device Catalogue Number: 254601
• Device Lot Number: 3698503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2013
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2013
• Initial Report FDA Received Date: 07/16/2018
• Patient Sequence Number: 1