MAUDE Adverse Event Report: DEPUY MITEK BIOCRYL INTERFERENCE SCREW, 8X23 MM; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Catalog Number	231710
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2015
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.The complaint device was received and evaluated.Visual observation confirms that the anchor is broken at the distal end.Typically, anchor breakages are associated with off -axis insertion, levering during insertion or hard bone quality.It was reported that the insertion was off-axis, which would have contributed to this event.The root cause of this failure is attributed to user technique.A batch record review has been conducted and 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 mitek complaints system revealed no other complaints of any kind for this lot released to distribution.At this point in time, based on the overall complaint rate, no further action is warranted.However, depuy synthes 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.(b)(4).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 affiliate in (b)(6) that during an anterior cruciate ligament (acl) repair surgical procedure, it was observed that the biocryl interference screw, 8x23 mm device was broken.The broken piece didn't fall into patient.It was reported that they changed to a new biocryl interference screw, 8x23 mm device to complete the procedure.It was not reported if there were any delays in the procedure.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: BIOCRYL INTERFERENCE SCREW, 8X23 MM
• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7771823
• Report Number: 1221934-2018-53714
• Device Sequence Number: 1392003
• Product Code: MAI
• UDI-Device Identifier: 10886705010608
• UDI-Public: 10886705010608
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/13/2015

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: 09/30/2016
• Device Catalogue Number: 231710
• Device Lot Number: 3728437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2015
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2015
• Initial Report FDA Received Date: 08/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1