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	05/16/2014
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 was received and evaluated.From visual inspection the device is shown to be cracked/broken along the high ribbed portion of the wings, confirming this complaint.Since the sheath broke on insertion, a possible cause of failure is the use of the wrong inserter.Since this information was not supplied, it is hard to determine a definite cause of failure.A batch review was 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 was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.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.Associated medwatch: 1221934-2018-53825 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 repair that the two of the customer's intrafix femoral sheath and screw systems, 8mm, broke when being inserted.The sales rep reported that the first sheath, under the scope, could be seen to be bending and turning a white color just before it broke.The surgeon completely removed this sheath and inserted a second sheath, different lot, in the same bonehole when under the scope they could see it bending and turning white again.The surgeon stopped inserting the sheath and attempted to remove it before it broke but was unable to do so.The surgeon completely removed this sheath and inserted a third, different lot number, same type of sheath in the same bonehole and completed the procedure with no patient consequences or delay.The sales rep reported that the surgeon dilated the tunnel according to our procedure and that his angle of insertion was perfect.

• 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: 7859110
• Report Number: 1221934-2018-54620
• Device Sequence Number: 1565652
• Product Code: MAI
• UDI-Device Identifier: 10886705013647
• UDI-Public: 10886705013647
• 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): 05/16/2014

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: 11/30/2016
• Device Catalogue Number: 254683
• Device Lot Number: 3741064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2014
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/16/2014
• Initial Report FDA Received Date: 09/10/2018
• Patient Sequence Number: 1