MAUDE Adverse Event Report: DEPUY MITEK LLC US VERSALOK THREADER TAB *EA; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number 210800

Device Problem Peeled/Delaminated (1454)

Patient Problem Not Applicable (3189)

Event Date 02/13/2018

Event Type  malfunction  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).Investigation summary: the complaint device is not available for physical evaluation, hence, the complaint cannot be confirmed.Given the information provided we cannot discern a definitive root cause for the reported failure.A device history record (dhr) review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.At this point, 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 rotator cuff repair surgical procedure, it was observed that there were metallic matter floating arthroscopically.It was reported that there was no breakage nor anomaly found in the device.It was reported that the device was brand new and on its first use when the issue occurred.There was a 10-minute-delay in surgery and no harm to the patient.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.

• Type of Device: SOFT-TISSUE ANCHOR, NON-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: 8175208
• MDR Text Key: 131213445
• Report Number: 1221934-2018-55719
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063478
• 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: 02/14/2018

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 Expiration Date: 10/31/2020
• Device Catalogue Number: 210800
• Device Lot Number: L621152
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/14/2018
• Initial Date FDA Received: 12/18/2018
• Date Device Manufactured: 11/13/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1