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 Known Impact Or Consequence To Patient (2692)
Date of Event	11/11/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Evaluation statement: the complaint device is not being returned, it was discarded and therefore is unavailable for a physical evaluation.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.Therefore, we cannot determine what caused the user to experience the reported event, 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 during an acl procedure that the customer's biointrafix 7x30 tapered screw broke about 2/3 of the way while being inserted.The surgeon removed the sheath and screw and used another like device to complete the procedure.The sales rep was not present, but stated the tensioner was used prior to insertion, but could not verify if the antirotation tab was at the 3 or 9 o'clock position.Also he could not verify the cortical or cancellous bone type.This extended the procedure about 5 minutes.Please see also medwatch report 1221934-2018-52307.

• 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: 7702914
• Report Number: 1221934-2018-52306
• Device Sequence Number: 10945668
• 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): 11/11/2013

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 Catalogue Number: 254622
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2013
• Initial Report FDA Received Date: 07/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1