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

Catalog Number 223129

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Not Applicable (3189)

Event Date 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).Investigation summary: it was noted that the complaint device will not be returning, hence a physical evaluation cannot be performed.Therefore, this complaint cannot be confirmed.No further information has been provided to determine a root cause for this failure, nor were pictures provided.If any additional information is obtained, this complaint will be re-opened to capture that information.Furthermore, a non-conformance search was performed, and no non-conformances were identified for this part (223129), lot (l936777) combination.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.

Event Description

It was reported by the affiliate in (b)(6) that during arcr surgery, it was observed that the anchor came off right after the implantation of the anchor.According to the report, the event occurred when the reported anchor was implanted inside the attachment part of the cuff of the humerus bone.There was less than 30 minutes of delay in the surgical procedure.The surgery was completed without any other problem although it was not reported how.It was reported that the device was brand new and its first use when the issue occurred.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.

• 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
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 8204029
• MDR Text Key: 131708942
• Report Number: 1221934-2018-55869
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705024735
• UDI-Public: 10886705024735
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2018

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 Catalogue Number: 223129
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 12/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1