MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL RGDLOOP ADJUSTABLE STND; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number 232447

Device Problem Break (1069)

Patient Problems Tissue Damage (2104); Not Applicable (3189); No Code Available (3191)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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).

Event Description

It was reported by affiliate via complaint submission tool that during acl reconstruction surgery, working with the rgdloop adjustable stnd, after the button had exited the femoral cortex and flipped we tried to pull the white suture to advance the graft into the femoral tunnel.As we pulled on the white suture it snapped.We had to pull the button out through the proximal skin incision open a new button and put the graft on the new button.Then we proceeded to finish the acl.No patient consequences.There is surgical delay of 8 minutes reported.The device was discarded.

Manufacturer Narrative

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.Investigation summary : the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (5l45074), and no non-conformances were identified.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.Device history lot : a manufacturing record evaluation was performed for the finished device lot number (5l45074), and no non-conformances were identified.

• Brand Name: RGDLOOP ADJUSTABLE STND
• 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: 10059605
• MDR Text Key: 191096779
• Report Number: 1221934-2020-01383
• 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
• Type of Report: Initial,Followup
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 232447
• Device Catalogue Number: 232447
• Device Lot Number: 5L45074
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2020
• Patient Sequence Number: 1