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

Model Number 223129

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2019

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.(b)(4).

Event Description

It was reported by affiliate via personal interaction, that during a rotator cuff repair the surgeon used a 4.5 healix advance br 3 suture anchor w/ permacord, and while inserting the anchor to the greater tubercle, the anchor cracked and was retracted.The surgeon commented that another anchor was inserted into the subscapularis muscle prior to the insertion of the anchor in question.The anchor in question might have made contact with the previously inserted one.No surgical delay or patient consequence reported.Additional information received from the affiliate reported the case was completed but could not provide additional details.The affiliate also replied the device is not available for evaluation.

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.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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> the complaint device is not being returned, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.  a manufacturing record evaluation was performed for the finished device [4l88383] number, and no non-conformances were identified   since the complaint device was not returned, we cannot determine a root cause for the reported failure.If the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.  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.Device history lot
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> a manufacturing record evaluation was performed for the finished device [4l88383] number, and no non-conformances were identified.

• 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: 9527087
• MDR Text Key: 207774683
• Report Number: 1221934-2019-60186
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 223129
• Device Catalogue Number: 223129
• Device Lot Number: 4L88383
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2020
• Patient Sequence Number: 1