MAUDE Adverse Event Report: DEPUY MITEK LLC US INTRAFIX FEMORAL SHEATH & SCREW SYSTEM, 7.5 MM; ORTHOPAEDIC BONE SCREW, NON-BIOABSORBABLE, STERILE

Catalog Number	254681
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/05/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The batch review 3449397 showed that the devices were conformed to in process and finished goods specifications when released to stock the 9 aug.2010.Expiration date: 2013-07 (according to retained labels).No nc was opened.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.Further, a review into the depuy mitek complaints system revealed 1 other complaint for this lot of devices that were released to distribution, but the failure mode was for a screw cracking and not a full breakage.These complaints are not related to each other based of failure mode.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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The sales rep reported one of his intrafix 7.5mm femoral screws broke upon insertion into the sheath during an acl procedure.He stated the device started to crack as the surgeon inserted the device and continued anyways and then the screw broke in two pieces.The surgeon removed all fragments of the screw but kept the sheath in the patient then inserted a new screw to complete the procedure with no patient consequences or delays.The device was already discarded by the customer.The sales rep stated this was a (b)(6) female with hard bone and believes the surgeon should have used a different type of screw for the type of bone.No further details are available.

• Brand Name: INTRAFIX FEMORAL SHEATH & SCREW SYSTEM, 7.5 MM
• 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: 7687232
• Report Number: 1221934-2018-51145
• Device Sequence Number: 683665
• Product Code: MAI
• UDI-Device Identifier: 10886705013623
• UDI-Public: 10886705013623
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 08/05/2013

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: 07/31/2013
• Device Catalogue Number: 254681
• Device Lot Number: 3449397
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2013
• Initial Report FDA Received Date: 07/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 19 YR