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

Model Number 232448

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2018

Event Type  malfunction  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4) incomplete the exp date is currently unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported by the affiliate in (b)(6) that during acl (ant cruciate ligament) reconstruction surgical procedure, while using the rigid loop adjustable long implant, the surgeon was reducing the loop of the implant, and this presents difficulties when it was blocked, so that by pulling the white thread with the help of a clamp, a force greater than usual must be exerted.Thus, the thread breaks in the proximal portion at the site where the force of the vector is exerted without reaching the point where the loop is blocked.It is checked intra-articularly and one of the two loops of the loop where the graft is lodged is broken, so that the graft was not reduced without reaching the desired position and therefore it was loosened, the implant had to be removed and another one used.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.

Manufacturer Narrative

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 device was received and evaluated.Visual inspection confirms that 2 strands of the white suture are broken and frayed.There were no anomalies on the other suture or the anchor.This complaint is confirmed.As per the provided information, an excessive force might have applied by surgeon while pulling the white thread with the help of a clamp.It is possible excessive force or tension may have caused the reported condition.One other possible root cause, due to contact with a sharp instrument(clamp) during the procedure which damaged the suture resulting in it breaking.The fraying found on the returned suture could be an indication of this.A manufacturing record evaluation was reviewed, no non-conformances were identified for the reported part 232448- lot l918843 number combination.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 review: a manufacturing record evaluation was reviewed, no non-conformances were identified for the reported part 232448- lot l918843 number combination.

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.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: despite multiple attempts made to the affiliate for the return of the complaint device, the device has not been received for evaluation.We cannot determine what caused the user to experience the reported event; we cannot discern a root cause for the reported failure mode.This complaint cannot be confirmed.No nonconformances were identified for this part-lot number combination qlik query executed 2-7-2019.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.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).The expiration date is unknown.

• Brand Name: RGDLOOP ADJUSTABLE LONG
• 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: 8197470
• MDR Text Key: 131492090
• Report Number: 1221934-2018-55847
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705024100
• UDI-Public: 10886705024100
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 232448
• Device Catalogue Number: 232448
• Device Lot Number: L918843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Date Manufacturer Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 76