MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT X-LARGE; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	232449
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/07/2015
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.Investigation summary: the complaint device is not being returned, therefore unavailable for a physical evaluation.A review into the depuy mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.We cannot discern a root cause for the reported failure mode.A review of the device history record indicated that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.At this point in time, no corrective action is required and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.However, 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.This report is being filed from the etq 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 during an anterior cruciate ligament (acl) reconstruction, while tightening the graft, the loop suture snapped on the graft side of the button.This has caused the rigidloop adjustable button to be unusable.In turn, this has increased the surgical time by approximately twenty (20) minutes, and the acl repair is not of the standard required.The following additional information was received via e-mail from the affiliate on october 13, 2015: it was noted the surgeon was using the implant "off-label".He was using the implant on the tibia, and not the femur as indicated.He has advised me that due to his graft prep technique, he had additional sutures from the graft that he threaded through the rigid loop adjustable bar and tied off to complete the procedure.It was noted it is highly likely that the surgeon assistant damaged the loop suture during the graft prep leading to the breakage.

• Brand Name: RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT X-LARGE
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle ; SZ
• MDR Report Key: 7870440
• Report Number: 1221934-2018-50780
• Device Sequence Number: 2114068
• Product Code: MBI
• UDI-Device Identifier: 10886705024117
• UDI-Public: 10886705024117
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/07/2015

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 232449
• Device Lot Number: 3803117
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2015
• Initial Report FDA Received Date: 09/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1