MAUDE Adverse Event Report: DEPUY MITEK LLC US FEM.INTRAFIXSHEATH&SCRSYS,9MM; ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, STERILE

Model Number	254684
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/16/2013
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.Evaluation statement the complaint device is not being returned, therefore is unavailable for a physical evaluation.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.A capa has been opened to investigate this failure mode.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.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.However, 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.(b)(4).
Event or Problem Description
The sales rep reported that the screw of the customer's intrafix femoral sheath and screw system, 9mm broke upon insertion.The sales rep stated the screw was about 1/4 of the way in the bone hole when it broke at that point.The surgeon used a dilator to prepare the hole and was very familiar with the product having used it since it's inception.The surgeon completed the procedure with the device with no patient consequences or delay.The anchor was left securely in the bone hole.The sales rep reported the bone quality was hard.The sales rep was not present and could not provide any more information.

• Brand Name: FEM.INTRAFIXSHEATH&SCRSYS,9MM
• 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: 7689216
• Report Number: 1221934-2018-51168
• Device Sequence Number: 2771706
• Product Code: MAI
• UDI-Device Identifier: 10886705013654
• UDI-Public: (01)10886705013654(10)3680959(17)160229
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/20/2013

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: 02/29/2016
• Device Model Number: 254684
• Device Catalogue Number: 254684
• Device Lot Number: 3680959
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2013
• Initial Report FDA Received Date: 07/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1