MAUDE Adverse Event Report: DEPUY MITEK RIGIDFIX BIOCRYL BTB 2.7 MM CROSS PIN KIT; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	210815
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2015
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 reveals a number of anomalies.The locking pins on the trocar are sheared off, confirming this complaint.The distal end of the trocar is heavily damaged which is consistent with the trocar hitting the side of the femoral rod.The sleeves were not returned so could not be evaluated.From the anomalies observed, we determine the quality of the bone and user technique to be the root cause of this failure.A batch record review has been conducted for this lot and the 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 no other complaints for this lot.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.(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 sales rep that during an anterior cruciate ligament (acl) surgical procedure, it was observed that the wings on the customer's rigidfix biocryl btb 2.7mm cross pin kit drill bit that hold the sheath in place broke off while drilling.The sales rep stated that the device broke outside the patient and he confirmed no debris in patient.The surgeon completed the procedure with another like device with no patient consequences or delays.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: RIGIDFIX BIOCRYL BTB 2.7 MM CROSS PIN KIT
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7771635
• Report Number: 1221934-2018-53591
• Device Sequence Number: 16491774
• Product Code: MAI
• UDI-Device Identifier: 10886705001293
• UDI-Public: 10886705001293
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/03/2015

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: 12/31/2017
• Device Catalogue Number: 210815
• Device Lot Number: 3821593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2015
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2015
• 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