MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL RIGIDLOOP IMPLANT, 20MM; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	232011
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/09/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate the complaint device was received and inspected by npd engineering.Visual inspection revealed a clean separation of the tails of the ultra high molecular weight polyethylene loop.Based on this clean separation, the lock-stitching was determined to be missing, confirming the failure mode.This missing lock-stitch failure results from not following procedure, which describes the process to lock-stitch the rigidloop device during manufacturing.Corrective actions were taken to update the procedures in order to have a second operator checking the lock-stitching operation as part of the investigation.A review into the depuy mitek complaints system revealed no other complaints for this lot released to distribution.Depuy 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 remetrex complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during gracilis femitendinosis transplant, the suture and polyethylene loop had separated.According to the report, the surgeon passed the graft through the loop until the loop was at the mid-point of the graft.With a surgical marker, he made a mark on the graft for the femoral socket drill depth.Using a passing suture, he pulled the leading (white) and trailing (green) sutures through the tibial and femoral tunnels.Then he used the white leading suture to pull the implant/graft through the femoral tunnel until the mark on the graft was visible at the aperture.In this part the loop broke and doctor took s&n endobutton implant.The procedure was completed using s&n endobutton.It was reported that the issue did not extend the procedure longer than 30 minutes.It was not reported if there were any delays in a surgical procedure or if a spare device was available.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: RIGIDLOOP IMPLANT, 20MM
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7804636
• Report Number: 1221934-2018-51654
• Device Sequence Number: 1249569
• Product Code: MBI
• UDI-Device Identifier: 10886705022656
• UDI-Public: 10886705022656
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K130814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/12/2013

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2016
• Device Catalogue Number: 232011
• Device Lot Number: 3722913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2014
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2013
• Initial Report FDA Received Date: 08/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1