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

Catalog Number	254601
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation statement: to date attempts to retrieve the device have been unsuccessful, the complaint device has not been returned.Should at some point the complaint device is returned, the file will be re-opened so the evaluation and root cause can be added.A batch 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 and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.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.No preventative or corrective action is required.(b)(6).(b)(4).
Event or Problem Description
It was reported that the device has been broken during screwing screw into it.To complete the procedure customer used another one device the same type.
Additional Manufacturer Narrative
Evaluation statement to date attempts to retrieve the device have been unsuccessful, the complaint device has not been returned.Should at some point the complaint device is returned, the file will be re-opened so the evaluation and root cause can be added.A batch 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 and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.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.No preventative or corrective action is required.Udi: (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.

• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7669131
• Report Number: 1221934-2018-51068
• Device Sequence Number: 920858
• Product Code: MAI
• UDI-Device Identifier: 10886705013074
• UDI-Public: 10886705013074
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2013

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: 05/01/2014
• Device Catalogue Number: 254601
• Device Lot Number: 3538303
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/20/2013
• Supplement Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 07/09/2018
• Supplement Report FDA Received Date: 07/10/2018
• Patient Sequence Number: 1