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

Catalog Number 232447

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2015

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.Evaluation statement: the complaint device is not being returned, therefore is unavailable for a physical evaluation.A batch record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.We cannot discern a root cause for the reported failure mode.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) complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.

Event Description

The sales rep reported that during an acl procedure their rigidloop adjustable cortical implant while pulling the graft thru the femoral tunnel, the knot that holds the loop in place loosed and lengthened.The surgeon did not have to back the screw out, he pulled the graft up.The surgeon cycled the knee, re-tensioned the femoral side using white suture after tibial fixation tension was applied during tibial fixation.The sales rep reported that the order of suture was white, green/white, and green.The sales rep reported that the procedure was an am, graft size was unknown, femoral tunnel size was unknown and tibial tunnel size was unknown.The sales rep confirmed that the surgeon was able to complete the procedure with the device with no patient consequences but there was a five minute delay in the case.The sales rep was not present for the case and could not provide any further information.The sales rep reported that the device was discarded.

• 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
• Manufacturer (Section G): MEDOS SARL; rue du puits-godet 20; neuchâtel CH-20 00; SZ CH-2000
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7750383
• MDR Text Key: 116070197
• Report Number: 1221934-2018-53347
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705024094
• UDI-Public: 10886705024094
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/20/2015

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: 08/31/2017
• Device Catalogue Number: 232447
• Device Lot Number: 3794916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2015
• Initial Date FDA Received: 08/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1