MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX TI ANCHR W/OC +NDLS; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number 222242

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Code Available (3191)

Event Date 06/06/2019

Event Type  Injury  

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.Initial reporter phone number: (b)(6).Udi: (b)(4).The expiration date is unknown.

Event Description

It was reported by the affiliate via cst that during a rotulian tendon reconstruction the 5.5 healix ti anchor with orthocord and needles was used with a punch starter and passed without problems.The surgeon began to repair the tendon with one of the threads, and when he went to take a top thread, the thread was sheared and frayed, which is broken, and the four strands of the anchor were released.Obviously, it was necessary to replace it for another one and as they did not have the same thread, a fastin 5.0 was used, and with this second healix to make the repair.The surgery was completed successfully.It is unknown if fragments were created.There was no surgical delay.No patient consequence.

Manufacturer Narrative

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 the information is unknown, not available or does not apply, the section/field of the form is left blank.The complaint device was received and evaluated.Upon visual evaluation, it was found that the device was incomplete as it was missing the cover handle, suture card and the anchor.Only the healix driver and the handle were returned.The sutures were not returned; therefore, the complaint can't be confirmed.A root cause cannot be determined as the components did not return with the device for a physical evaluation.Furthermore, a non-conformance search was performed and no non-conformances were identified for this part number, lot number combination per qlik query executed on 6/10/2019.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.No nonconformances were identified for this part number, lot number combination per qlik query executed on 6/10/2019.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.H10 additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional information: (b5): event description.

Event Description

Additional information received from the affiliate reported the procedure was not an arthroscopic surgery.The affiliate also reported additional information is not available.

Manufacturer Narrative

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 the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: d10 h3, h6: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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: 5.5 HEALIX TI ANCHR W/OC +NDLS
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8769403
• MDR Text Key: 150376119
• Report Number: 1221934-2019-57557
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886705007882
• UDI-Public: 10886705007882
• Combination Product (y/n): N
• PMA/PMN Number: K082282
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 222242
• Device Lot Number: L303271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Date Manufacturer Received: 09/03/2019
• Patient Sequence Number: 1