MAUDE Adverse Event Report: DEPUY MITEK LLC US PROFILE INTSCR 9X25MM *EA; LIGAMENT ANCHOR

Catalog Number	230525
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).The exp date is currently unavailable.The complaint device was received and evaluated.Visual inspection revealed that the screw was in used condition with tissue debris present.Further microscopic inspection revealed no structural damage to the screw.Functionally, the hex driver was tested with the screw and found no difficulty in removing or inserting the driver.This complaint could not be confirmed.Further, a review into the depuy synthes mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.At this point in time, no corrective action is required and 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.A non-conformance search was performed for this product code 230525, lot 3669173 combination and no non-conformances were identified.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.At this point in time, no corrective action is required, and no further action is warranted.This report is being filed from the etq 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 repair surgical procedure, it was observed that the tip of the customer's hex driver, 4.0 became stuck in the head of the screw upon insertion.When the surgeon removed the driver after inserting the screw, the screw came out at the same time.The surgeon used another like device with another screw in the same bone tunnel 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.

• Common Device Name: LIGAMENT ANCHOR
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8245586
• Report Number: 1221934-2018-51905
• Device Sequence Number: 2389149
• Product Code: HWC
• UDI-Device Identifier: 10886705010509
• UDI-Public: 10886705010509
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K961234
• 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): 03/11/2016

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: 230525
• Device Lot Number: 3669173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2016
• Initial Report FDA Received Date: 01/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1