MAUDE Adverse Event Report: DEPUY MITEK LLC US BIOKNOTLESS PLUS W/OC; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number 212726

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Device was used for treatment, not diagnosis.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).The expiration date is not currently available.

Event Description

It was reported by the sales rep that two of their anchors bent when it was being inserted into the patient during a labral repair.There were no patient consequences or delays.The case was completed with a third like device.The devices were discarded by the customer.

Manufacturer Narrative

Product complaint # (b)(4).Device was used for treatment, not diagnosis.Investigation summary : the complaint device was discarded and not available for evaluation.Therefore, we cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode.A dhr review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.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 depuy mitek complaints system revealed one similar complaint 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 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: BIOKNOTLESS PLUS W/OC
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7290752
• MDR Text Key: 101025113
• Report Number: 1221934-2018-50213
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 212726
• Device Lot Number: L421829
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1