MAUDE Adverse Event Report: DEPUY MITEK VERSALOK ANCHOR WITH ORTHOCORD; MITEK ANCHOR IMPLANTS

Catalog Number 210808

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Code Available (3191)

Event Date 04/22/2016

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Associated medwatch: 1221934-2016-10213.(b)(4).

Event Description

When the physician has placed the implant, the versalok was not fixed.The physician was decided use a second versalok implant but it was not fixed.The device is removed and other device is placed.Additional information received via email from the affiliate on 5-3-2016; the same hole was used to complete the procedure; this failure extended the procedure time about 120 minutes.

Manufacturer Narrative

The complaint device is not available for a physical evaluation.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.A batch record review has been conducted and the results indicate that this batch of product was processed without any incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.At this point in time, no further action is warranted.However, should any new information be provided in future, this file will be re-opened and a thorough investigation will be performed.Depuy 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.Udi: (b)(4).

• Brand Name: VERSALOK ANCHOR WITH ORTHOCORD
• Type of Device: MITEK ANCHOR IMPLANTS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808210
• MDR Report Key: 5649464
• MDR Text Key: 44994735
• Report Number: 1221934-2016-10214
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK063478
• 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,Followup
• Report Date: 04/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 210808
• Device Lot Number: 3885418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2016
• Date Manufacturer Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other