MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX ADVANCE PEEK W/OC; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number 222305

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Injury (2348); Foreign Body In Patient (2687); Not Applicable (3189); No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).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

This is report 1 of 3 for the same event.It was reported by the affiliate in (b)(6) that during a shoulder repair procedure, it was observed that three 5.5 healix advance peek anchor with orthocord violet threads broke about five centimeters behind the knot.The surgeon opened an additional anchor.There was no harm to the patient, but there was approximately a fifteen minute surgical delay.It was reported that the implants (anchors) were left in place.In 3 of 4 anchors the same-cholored thread ruptured.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Additional information received from the affiliate reporting that 3 sutures broke intra-op while trying to tie knots with hand tension.The affiliate also reported that the initial surgical plan included to use 4 anchors: 2 for ssp and 2 for ssc.4 anchors were used.In 3 out of 4 anchors the violet suture broke.No additional bone holes were created due to the alleged suture break.There were no known patient consequences but the affiliate reported but in the future maybe an insufficiency of the cuff repair, as 3 simple sutures had to be applied, instead of mason-allan-configuration.

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.H10 additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Corrected data: (h6) patient codes investigation summary: only the broken pieces of suture were returned for evaluation from three complaint anchors reported as complaint devices.The three complaint devices were all from the same lot and it is impossible to determine which pieces belong to which anchor.There were 6 pieces of suture returned.Three of them had knots in them and three other smaller pieces.The ends of the suture were frayed.There were no other anomalies on the suture.The three pieces with the knots were taken to a lab and pull tested.The minimum requirement for this type of suture is 48.6 lbs.The three sections of the suture were pull tested until they broke and they all exceeded the minimum 46.8 lb.Limit.There was no further information provided that would help determine the root cause of this failure.One potential root cause was that the suture could have come in contact with a sharp instrument or an excessive force was used when tensioning the suture.The fraying of the suture could be an indication of this.This compliant can be confirmed.A manufacturing record evaluation (all three reported device are from the same lot number) was performed on 5/15/2019 for the finished device lot number, and no non-conformances related to the reported complaint condition were identified.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.Udi: (b)(4).

• Brand Name: 5.5 HEALIX ADVANCE PEEK W/OC
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8662884
• MDR Text Key: 147944986
• Report Number: 1221934-2019-57280
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886705021413
• UDI-Public: 10886705021413
• Combination Product (y/n): N
• PMA/PMN Number: K120449
• 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: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 222305
• Device Lot Number: 2L82219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Date Manufacturer Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1