MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.5 HEALIX TI ANCHOR W/OCORD; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number 222253

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2015

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.Only a section of suture was received with this complaint.The ends of the suture are frayed.This complaint can be confirmed.The possible root causes of the suture break are excessive force placed on the suture when tightening or coming in contact with a sharp object.There was not enough information provided with the complaint to be able to make a determination of the root cause beyond these two possibilities.Two lot numbers were provided with the returned suture and the affiliate was unable to identify which lot the broken suture was from.A review into the depuy synthes mitek complaints system revealed no other complaints for both of these lot numbers.At this point in time, no corrective action is required and no further action is warranted.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.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.

Event Description

This is report 1 of 2 for the same event.It was reported by the affiliate in (b)(6) that during a fracture repair surgical procedure, it was observed that the thread broke while the surgeon was knotting the suture anchor.According to the reporter, two anchors were used but the surgeon did not know which thread broke.It was reported that both anchors were implanted.It was reported that the second anchor was used to complete the procedure with a ten minute delay.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

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 medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: only a section of suture was received with this complaint.The ends of the suture are frayed.This complaint can be confirmed.The possible root causes of the suture break are excessive force placed on the suture when tightening or coming in contact with a sharp object.There was not enough information provided with the complaint to be able to make a determination of the root cause beyond these two possibilities.Two lot numbers were provided with the returned suture and the affiliate was unable to identify which lot the broken suture was from.A review into the depuy synthes mitek complaints system revealed no other complaints for both of these lot numbers.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.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.Associated medwatch: 1221934-2019-55986.

• Brand Name: 4.5 HEALIX TI ANCHOR W/OCORD
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8243647
• MDR Text Key: 133867313
• Report Number: 1221934-2018-50804
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886705007998
• UDI-Public: 10886705007998
• Combination Product (y/n): N
• PMA/PMN Number: K082282
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 222253
• Device Lot Number: 3821752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2016
• Date Manufacturer Received: 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1