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

Catalog Number 232447

Device Problems Break (1069); Material Frayed (1262)

Patient Problem Not Applicable (3189)

Event Date 07/23/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4), incomplete.The lot number is unknown.

Event Description

It was reported by the affiliate via email that one rigid-loop adjustable standard initially snapped.It was either lot no 3l87587 or lot no 3l05579.They don't know which as both were opened at the same time.These were both replaced with 2 more rigid-loop and one of these snapped, either lot 2l71383 or lot 4l01952 again not sure which one.The customer then used a rigid-loop adjustable large (232449) that was ok.The case was delayed by approximately 60 minutes.Additional information provided by the affiliate reported that the complaint devices are not available for return.It was also reported by the affiliate that 4 devices were used in total to complete the procedure.It was also stated that the white suture broke and it is not possible to locate the appropriate lot numbers of the failed devices.The affiliate also reported rongeurs instruments were in use with the rigid loop devices.It was also reported there were no known patient consequences and the case was completed with the ridgelook adjustable large device.

Manufacturer Narrative

Depuy synthes mitek 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.H10 additional narrative: h3, h6: investigation summary the complaint device is not being returned, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.Our affiliate mentioned two lot numbers and stated that either of them has the reported issue but could not specify which one.Per qlik query executed on 09/18/2019 with both lot numbers, 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.H3, h4, h6: a review of the device history record device history lot per qlik query executed on 09/18/2019 with both lot numbers (3l87587 and 3l05579), no non-conformances were identified.Device history batch, device history review null.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.

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.H11 corrected data: h6: corrected product code.D4: lot number is either 3l87587 or 3l05579.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.

• 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: 8914972
• MDR Text Key: 155346368
• Report Number: 1221934-2019-58067
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2019

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 Catalogue Number: 232447
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 08/21/2019
• Supplement Dates Manufacturer Received: 09/04/2019; 09/18/2019
• Supplement Dates FDA Received: 09/05/2019; 10/15/2019
• Patient Sequence Number: 1