MAUDE Adverse Event Report: DEPUY MITEK LLC US VERSALOK ANCHOR W/ORTHOCORD PEEK & TITANIUM ANCHOR; SCREW, FIXATION, BONE

Catalog Number 210808

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

The complaint device is not available for physical evaluation, hence, the complaint cannot be confirmed.Furthermore, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.No further information regarding the technique used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.At this point in time, no corrective and preventative 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.If information is obtained that was not available for the medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported by the sales rep that the customer's versalok anchor was deployed but did not expand sub-cortically during a rotator cuff surgical procedure.The surgeon removed the failed device from the patient, before redeploying another versalok anchor to complete the surgery with minimal delays and no patient consequence.The device is not available for return.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: VERSALOK ANCHOR W/ORTHOCORD PEEK & TITANIUM ANCHOR
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7944033
• MDR Text Key: 123500407
• Report Number: 1221934-2018-54818
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886705001224
• UDI-Public: 10886705001224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/17/2018

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: 210808
• Device Lot Number: N/I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2018
• Initial Date FDA Received: 10/08/2018
• 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: Unknown
• Patient Sequence Number: 1