MAUDE Adverse Event Report: DEPUY MITEK LLC US BIOINTRAFIX TAPERED SCREW, 7MM X 30MM; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	254622
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint device was received and evaluated.Visual inspection revealed screw is broken.Based on complaint report, a possible cause of failure is the misuse with a different hex driver, 23mm instead of 30mm.This mismatch can cause the hex to not fully support the screw and the screw to break.Past cases have also revealed that screws can break if inserted off axis.The root cause of this failure can be attributed to costumer misuse.A batch review was also conducted for batch # 3662572.Our results indicate that this batch was processed without incident and therefore there is no internally assignable cause for the reported problem.Furthermore, a complaint search was done, revealing zero similar complaints for the lot of parts.At this point there is no further corrective action needed.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
It was reported that while performing an acl procedure and following successful steps to prepare tunnels and fixate the graft on the femoral side, surgeon began his fixation of the tibial side.He followed appropriate technique and inserted a small bio intrafix sheath with ease.He then began to insert the biointrafix screw (6-7) and the screw fractured one third the way in.He opened a second screw and sheath and repeated the steps and the second screw fractured at the same spot.Sales consultant spoke with him and the staff, to inquire about the hex driver that used.In my opinion the fracture is consistent with either a 23mm driver or the possibility of the screw not being fully inserted on the 30mm hex driver.Neither the staff nor the surgeon could confidently be certain that the driver was the 30mm.The surgeon implanted a milagro advance and was very satisfied with his fixation.Please see also medwatch report 1221934-2018-51901.

• Brand Name: BIOINTRAFIX TAPERED SCREW, 7MM X 30MM
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7799744
• Report Number: 1221934-2018-51899
• Device Sequence Number: 13972107
• Product Code: HWC
• UDI-Device Identifier: 10886705013197
• UDI-Public: 10886705013197
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K032167
• 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): 03/18/2014

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: 12/31/2015
• Device Catalogue Number: 254622
• Device Lot Number: 3662572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2014
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2014
• Initial Report FDA Received Date: 08/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1