MAUDE Adverse Event Report: DEPUY MITEK LLC US CRUCIATE+ BEATH PIN BULLET; LIGAMENT RECONSTRUCTION INSTRUMENT SET

Catalog Number	219003
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/16/2017
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.Out of the two complaint devices, only the beath pin was returned.The bullet was not returned and was thus unavailable for physical evaluation.The complaint device was received and evaluated.Visually, it was observed that the beath pin is slightly bent at the distal end.Galling was observed on the surface of the complaint device thus indicating friction between two surfaces.Per the reported complaint, the beath pin got stuck in the bullet.It was noted that it got stuck while drilling on the tibial tunnel.First pass was made using the bullet attached to the guide arm and the surgeon didn't like his location so he kept the bullet in position but detached from the guide arm and changed the angle for a second pass.He didn't like the angle again on the second pass and backed out the beath pin.Once the beath pin came out of the bone it locked up inside the bullet.A possible explanation for this failure could be that in the process of adjusting the angle of the pin, the surgeon eventually ended up aligning the beath pin off-axis thus causing the pin to get stuck in the bullet.The apparent wear and galling along with a slight bent on the distal end indicate that the pin was stuck and force was applied to separate it from the bullet.This complaint can thus be confirmed.The failure can be attributed to user technique issue.For the beath pin, a review into the mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.The lot number for the bullet was unknown which precludes conducting a dhr review or a lot specific search in the complaints handling system.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.(b)(4).This report is being filed from the (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported during an unknown procedure the acr drillpn w/eye and the cruciate + beath pin bullet became stuck together.The devices became stuck while drilling the tibial tunnel.The procedure was completed using a back-up tray.There was 39-second delay in surgery and no patient consequence.This report is 2 of 2 for (b)(4).

• Brand Name: CRUCIATE+ BEATH PIN BULLET
• Common Device Name: LIGAMENT RECONSTRUCTION INSTRUMENT SET
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8290072
• Report Number: 1221934-2018-53975
• Device Sequence Number: 1953292
• Product Code: LXH
• UDI-Device Identifier: 10886705025855
• UDI-Public: 10886705025855
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/16/2017

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: 219003
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2017
• Initial Report FDA Received Date: 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1