MAUDE Adverse Event Report: DEPUY MITEK RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number 213013

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/28/2017

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

The affiliate reported via email that the trocar got stuck into the cannula.No aes reported.Also, the laser marker was in a wrong position.No aes reported.There was no adverse patient consequences.The following additional information was received via email from the affiliate on (b)(6) 2017: the device was used in an acl procedure.The procedure was completed by using a new device and there was a five minute delay in the case.The trocar welded while being introduced into the cannula.The marker placement was wrong on the push rod assembly.

Manufacturer Narrative

In the reported event, the product code has multiple components associated with it.Two of those components had complaints reported on them- the trocar assembly and the pusher rod assembly.Only one sleeve of the trocar assembly and the pusher rod assembly was received back for evaluation.The trocar assembly: per the reported complaint, the trocar got welded into the cannula.However, the entire trocar assembly was not returned and hence was unavailable for physical evaluation.Only one sleeve of the trocar assembly was returned for evaluation.This sleeve looked to be in good condition.No apparent anomalies were observed.The reported issue cannot be confirmed.A review of the device history record indicated that this batch of product was released through an unrelated non-conformance with no link to the reported issue and therefore there is no internally assignable cause for the reported problem.We cannot determine a root cause for the reported failure.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any type 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.The push rod assembly: per the reported complaint, the laser marker was in the incorrect position of the push rod assembly.Photos of the complaint device were received when the complaint was first reported.The photos of the device showed that the laser marking was in the correct location as reference to the released drawing.The complaint device (pusher rod assembly) was received and evaluated.The received complaint device was compared to the released drawing of the pusher rod assembly.It was observed that the laser marking was in fact in the correct position per the released drawing.Visually, the pusher rod looked to be in good condition and no anomalies or discrepancies could be observed.Hence, we could not confirm the reported complaint.No root cause could be determined as the device was found to be conforming to the released drawing.A review of the device history record revealed the lot was linked to a non-conformance for the push rod assembled with the wrong orientation to the handle.No non-conformance was found with this lot and it was dispositioned for release.Further, a review into the depuy synthes mitek complaints system revealed no complaints of any type for this lot of devices that were released to distribution.At this point in time, 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).

Event Description

The affiliate reported via email that the trocar got stuck into the cannula.No aes reported.Also, the laser marker was in a wrong position.No aes reported.There was no adverse patient consequences.The following additional information was received via email from the affiliate on 11-29-17: the device was used in an acl procedure.The procedure was completed by using a new device and there was a five minute delay in the case.The trocar welded while being introduced into the cannula.The marker placement was wrong on the push rod assembly.

• Brand Name: RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS SARL; puits godet 20; neuchatel CH 20 00; SZ CH 2000
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 7118021
• MDR Text Key: 95743192
• Report Number: 1221934-2017-10711
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/31/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 213013
• Device Lot Number: L320069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 08/31/2017
• Initial Date Manufacturer Received: 08/31/2017
• Initial Date FDA Received: 12/14/2017
• Supplement Dates Manufacturer Received: 12/21/2017
• Supplement Dates FDA Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1