MAUDE Adverse Event Report: DEPUY MITEK LLC US BIOINTRAFIX 6-7MMX30MMTPRSCR; 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	04/23/2015
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 inspected.Visual observation reveals the distal end of the screw is broken.When inspected under magnification, the screw revealed no structural anomalies that could have contributed to this failure.Additionally, the threads on the anchor appear stressed consistent with it being inserted into the bone.The reported condition can be confirmed but whether the incident occurred out-of-box is not confirmed.Although a definitive root cause cannot be discerned for this failure, in the past it has been observed that this type of screw breakage at its distal end, is a result of excessive torque applied during insertion or off angle insertion into the bone hole.A batch record review has been conducted and our results indicate that this batch of product was processed with one unrelated incident to this complaint and therefore there is no internally assignable cause for the reported problem.Further, a review into the mitek complaints system revealed no other complaints of any type for this lot of 500 devices that were released to distribution in 2014.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.
Event or Problem Description
It was reported that during an acl procedure, the surgeon noted the breakage of nail (anchor).Changed the new one to complete the procedure.There was no report on patient injury.

• Brand Name: BIOINTRAFIX 6-7MMX30MMTPRSCR
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7848703
• Report Number: 1221934-2018-54329
• Device Sequence Number: 1574270
• Product Code: HWC
• UDI-Device Identifier: 10886705013197
• UDI-Public: 10886705013197
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K032167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/25/2015

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: 02/28/2017
• Device Catalogue Number: 254622
• Device Lot Number: 3763924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2015
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2015
• Initial Report FDA Received Date: 09/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1