MAUDE Adverse Event Report: DEPUY MITEK KNOT MANIPULATOR FULL LOOP; MITEK ARTHROSCOPIC INSTRUMENTS

Catalog Number 214615

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 01/29/2016

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 #: 1221934-2016-10061.(b)(4).The lot number is not available.Awaiting device return.

Event Description

Implanted lupine anchor to perform a biceps tenodesis.Anchor was inserted and then tension was pulled.During knot tying of anchor, the knot pusher cut the suture and made the anchor useless.We opened up another anchor and another knot pusher from another set.We implanted the new anchor 5mm from the other anchor.The anchor was tied with another knot pusher without incident.

Manufacturer Narrative

The complaint device is not being returned; it was discarded by the customer and therefore is unavailable for a physical evaluation.This complaint cannot be confirmed.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.Therefore, we cannot determine what caused the user to experience the reported event; we cannot discern a root cause for the reported failure mode, however the age of the device is unknown; and it is possible the device could be old or has received heavy use and has come in contact with other metal instruments through use over time creating a sharp edge which then cut the suture of the anchor.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).Device discarded by customer.

Event Description

Implanted lupine anchor to perform a biceps tenodesis.Anchor was inserted and then tension was pulled.During knot tying of anchor, the knot pusher cut the suture and made the anchor useless.We opened up another anchor and another knot pusher from another set.We implanted the new anchor 5mm from the other anchor.The anchor was tied with another knot pusher without incident.Information received from our sales rep via email on 3-4-16 and 3-22-16 indicates both complaint devices were discarded by the customer.See associated medwatch #: 1221934-2016-10061.

• Brand Name: KNOT MANIPULATOR FULL LOOP
• Type of Device: MITEK ARTHROSCOPIC INSTRUMENTS
• 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: 5464759
• MDR Text Key: 39202017
• Report Number: 1221934-2016-10060
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/29/2016

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: 214615
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 01/29/2016
• Initial Date Manufacturer Received: 01/29/2016
• Initial Date FDA Received: 02/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other