MAUDE Adverse Event Report: DEPUY MITEK LLC US RIGIDFIX FEM 3.3MM S/T XPIN; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number 210133

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

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).Associated medwatches [mr#1221934-2018-50497] [mr#1221934-2018-50498] [mr#1221934-2018-50499].

Event Description

It was reported that the theatre team ended up using 4 x sets of implants whilst using the rigidfix cross pin set.This is due to a couple of problems that the surgeon encountered: the small pins on the trocar would snap off while trying to drive the trocar/sleeve combination through the alignment jig and into the femur.On two instances, the sleeve ended up fusing to the trocar.On the 4th (and final) implant available, the surgeon made the decision to leave only one pin for fixation (rather than the recommended two pins) due to the problems encountered.In this instance, he said that the fixation still felt good and was confident that the implant would still perform.The whole incident added 30 minutes onto the procedure.All trocars and sleeves have been kept and decontaminated for inspection and can be returned at your request.The hospital have requested that x3 rigidfix cross pin implants be replaced free of charge as this was an incident that was out of their control.I notice that all x4 implants have different lot numbers which makes me question whether the actual alignment jig instrument is causing the problem and wonder if this also needs returning.Would it be possible to change this free of charge please? i have included the reference and of the instrument that was used in the incident and is still currently in use: description: rigidfix soft tissue guide frame ref: (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the complaint device was received and evaluated.Both the sleeve and the trocar were jammed together, and were unable to separate, confirming this complaint.Visually, the outer surface of the sleeve and trocar had deep groove marks scratches and nicks, indicating this device was used with a loose fit within the guide frame.The trocar interlocking pins are not present and could¿ve snapped off allowing the sleeve and trocar to cold welded together during drilling.There are two possible root causes for this type of failure, (1) could be that the interlocking pins on the trocar are not fully seated in the sleeve prior to the rotation of the trocar or (2), the guide frame was out of alignment with the sleeve which could lead the frame to bind up with the sleeve/trocar resulting in welding of the two parts.As reported in the complaint the devices received have all different lot numbers.When dissembling/ assembling the user must avoid mismatching the components to the rigidfix kit, mismatching of the plate numbers will cause the device to fail during use, however no information has been provided.This failure can be attributed to user technique.The dhr review indicated that this batch of devices were processed without incident, therefore, there is no evidence of manufacturing anomalies on the records reviewed.Furthermore, a review into the depuy mitek complaints system no other complaints of any kind for this lot of devices that were released to distribution.And at this 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.Udi: (b)(4).Associated medwatches [mr#1221934-2018-50497], [mr#1221934-2018-50498],[mr#1221934-2018-50499].

• Brand Name: RIGIDFIX FEM 3.3MM S/T XPIN
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7450613
• MDR Text Key: 106856162
• Report Number: 1221934-2018-50496
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 10886705000890
• UDI-Public: 10886705000890
• Combination Product (y/n): N
• PMA/PMN Number: K974341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 210133
• Device Lot Number: L245184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Date Manufacturer Received: 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1