MAUDE Adverse Event Report: DEPUY MITEK 3.0MM FASTIN® ANCHOR, SINGLE PACK; MITEK ANCHOR IMPLANTS

Catalog Number 222130

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/25/2017

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.(b)(4).

Event Description

The affiliate reported via email the patient had cervical posterior surgery on (b)(6) 2017.The device broke during operation.And around 3.0 mm broken piece was still in the patient.Changed another new one to complete the surgery additional information received on 7-31-2017.Broken piece was not retrieved.Another hole was made to complete the procedure.

Manufacturer Narrative

The complaint device was received and evaluated.Visual observation confirms that the distal tip is broken off and not returned with the device return.Given the current information, a definitive root cause could not be determined.Typically, these types of failures are attributed to over-torqueing the device upon insertion, improper preparation of the bone hole, and inserting the anchor at an off-axis causing an excessive force applied to one point of the anchor.A dhr has been conducted and our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the mitek complaints system revealed no other complaints of any type for this lot of devices that were released to distribution.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

• Brand Name: 3.0MM FASTIN® ANCHOR, SINGLE PACK
• Type of Device: MITEK ANCHOR IMPLANTS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 6815756
• MDR Text Key: 83473974
• Report Number: 1221934-2017-10452
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945203
• 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: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 222130
• Device Lot Number: 3891522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 07/27/2017
• Date Manufacturer Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2016
• 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