MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.5 HEALIXADV BR3SUTANC PCORD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 223129

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Not Applicable (3189)

Event Date 02/07/2020

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.(b)(6).(b)(4).The expiration date is unknown.

Event Description

It was reported by (b)(6) employee via email, that during a cuff repair, upon following the surgical technique and using the correct awl and tap, when trying to insert the healix advance br 3 suture anchor w/ permacord, and healix advance knottless br anchor tcp/plga absorbable anchor, they would pull out.As a solution, the surgeon used a 5.5 healix advance knottless and a 5.5 healix advance br w/permacord.No surgical delay or patient consequence reported.Items are available for return.Additional information provided by the affiliate reported there was a 15 minute surgical delay.It was also reported patient consequences were not observed.

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.H10 additional narrative: investigation summary
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> according to the information provided, it was reported that the anchor pulled out during the procedure.The complaint device was received and evaluated.Visual inspection revealed no anomalies on the anchor and sutures.Since the tray, handle and suture card were not received, it's no possible to further evaluate functionally the device.Therefore the complaint was not confirmed.At this moment, a definitive root cause cannot be established, possible root causes for the reported failure can be related to user technique, off axis insertion, levering during insertion, hard bone quality or using incorrect instrumentation for preparing bone hole; nevertheless it cannot be conclusively affirmed.A manufacturing record evaluation was performed for the finished device [l828432] number, and no non-conformances were identified at this 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 to monitor the extent to which this complaint is observed in the field.Device history lot
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> a manufacturing record evaluation was performed for the finished device [l828432] number, and no non-conformances were identified.

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.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.D10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 4.5 HEALIXADV BR3SUTANC PCORD
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9724053
• MDR Text Key: 201863311
• Report Number: 1221934-2020-00599
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705024735
• UDI-Public: 10886705024735
• Combination Product (y/n): N
• PMA/PMN Number: K133794
• 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: 02/07/2020

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 Model Number: 223129
• Device Catalogue Number: 223129
• Device Lot Number: L828432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Initial Date Manufacturer Received: 02/07/2020
• Initial Date FDA Received: 02/18/2020
• Supplement Dates Manufacturer Received: 03/19/2020; 03/27/2020
• Supplement Dates FDA Received: 03/20/2020; 03/30/2020
• Patient Sequence Number: 1