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	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device was received and evaluated.The screw and sheath were received.Visual inspection confirms the sheath is damaged at both distal and proximal ends, confirming this complaint.There was no anomaly with the returned screw.We cannot discern a root cause for the user to have experienced this issue.There was no information available on the preparation of the bone hole to determine if there were any discrepancies in the user technique.A batch record review has been conducted and our results indicate that this batch of product was processed without incident that could cause this failure.Further, a review into the mitek complaints system revealed one other dissimilar complaint for this lot of devices that were released to distribution.Therefore, no further actions are warranted at this time.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 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 that when the doctor inserted the femorial intrafix, the sheath is ruptured so the doctor must replace by similiar product.

• 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: 7733935
• Report Number: 1221934-2018-54247
• Device Sequence Number: 11160076
• Product Code: MAI
• UDI-Device Identifier: 10886705013647
• UDI-Public: 10886705013647
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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
• Report Date (Section B): 01/07/2015

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 Expiration Date: 01/31/2017
• Device Catalogue Number: 254683
• Device Lot Number: 3759611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2015
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2015
• Initial Report FDA Received Date: 07/30/2018
• Patient Sequence Number: 1