MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT, STANDARD; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number 232447

Device Problems Loose or Intermittent Connection (1371); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4)-incomplete.Lot number not available.

Event Description

It was reported via email from the npd staff engineer that during an acl procedure, the quad tendon was attached to two rigidloop adjustable implants with permatape suture using the expressew a/c passing device.The whip-stitched graft was then prepared using 20mm white speedtrap graft preparation devices.The implantation of the first rigidloop adjustable device was successful.During the second implantation, it became evident that the graft preparation was insufficient.The permatape suture extended from the graft, and the graft was insufficiently tensioned despite using the full adjustment on the rigidloop adjustable implant.The surgeon used the remaining suture tails on the rigidloop adjustable device to tension the graft, placing a healix advance knotless implant into the tibia and tus securing the tails.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.Investigation summary: the complaint device is not being returned.The device is not available for physical evaluation and hence this complaint cannot be confirmed.According to the event description, there were two rigidloop adjustable implants used for the tibial and the femoral fixation by the surgeon.However, according to the instructions for use (ifu), it was concluded that it was an off- label use because this implant is used just for the femoral fixation hence, this failure was most probably a user error due to failure to follow instructions given in the instructions for use (ifu).There was no lot number provided 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.Udi- (b)(4).Lot number not available.

• Brand Name: RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT, STANDARD
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7795057
• MDR Text Key: 117836698
• Report Number: 1221934-2018-54513
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705024094
• UDI-Public: 10886705024094
• Combination Product (y/n): N
• PMA/PMN Number: K140324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/19/2018

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 Catalogue Number: 232447
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2018
• Initial Date FDA Received: 08/17/2018
• Supplement Dates Manufacturer Received: 09/17/2018
• Supplement Dates FDA Received: 09/17/2018
• Patient Sequence Number: 1