MAUDE Adverse Event Report: DEPUY MITEK 6.5 HEALIX ADVANCE PEEK ANCHOR WITH ORTHOCORD; MITEK ANCHOR IMPLANTS

Catalog Number 222309

Device Problem Unstable (1667)

Patient Problem Tissue Damage (2104)

Event Date 02/28/2017

Event Type  Injury  

Manufacturer Narrative

The complaint device was discarded by the customer and is therefore unavailable for a physical evaluation.Furthermore, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.We cannot discern a root cause for the reported failure mode.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.(b)(4).Depuy synthes has been informed that the lot number is not available.Associated medwatch: 1221934-2017-10126, 1221934-2017-10127.

Event Description

Affiliate reported via email during arthroscopic rotator cuff repair, suture anchor became dislodged (from osteopenic bone).During attempts by surgeon to remove the loose anchor (arthroscopically), both devices, mentioned above, were damaged and failed to open / close effectively.Need replacing.Alternate device (from competitor tray of shoulder instruments) were used to eventually remove anchor.Two minute delay.No adverse event to patient.Additional information received via email from the affiliate on 3-3-17.The original bone hole was not used to complete the procedure.The bone hole left unfilled.Surgeon happy with repair with other anchors used.Lot numbers are as follows: ratcheted grasper - (214606) - 16j02.Suture manipulator - (214626) - 13e01.Additional information received via email from the affiliate on 3-20-17.No product information had been provided in relation to the anchor.Additional information received via email from the affiliate on 5-4-17.I have confirmed that it was a mitek helix peek 6.5 mm anchor (ref: (b)(4)).No record of lot number available.

• Brand Name: 6.5 HEALIX ADVANCE PEEK ANCHOR WITH ORTHOCORD
• 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: 6570459
• MDR Text Key: 75279887
• Report Number: 1221934-2017-10202
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K120449
• 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: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 222309
• Device Lot Number: UNKNOWN
• 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: 05/04/2017
• Initial Date Manufacturer Received: 05/04/2017
• Initial Date FDA Received: 05/16/2017
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other