MAUDE Adverse Event Report: DEPUY MITEK LLC US OMNISPAN MENISCAL REPAIR 12DEG; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number 228141

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).The expiration date is not currently available.

Event Description

It was reported that semilunar needle broke during inserting into bone tunnel.The patient is (b)(6).And the bone quality is well.Enclosed please find the breakage photos.Changed another one to complete.

Manufacturer Narrative

Product complaint # (b)(4).Device was used for treatment, not diagnosis.Investigation summary: the complaint device was received and evaluated.Visual observation confirms this complaint that the needle is bent at an angle beyond its intended design.This failure can be attributed to patient being young with very good bone quality and the user technique where excessive force was applied on the device causing it to bend.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 synthes mitek complaints system revealed two other dissimilar complaints 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.Udi: (b)(4).

• Brand Name: OMNISPAN MENISCAL REPAIR 12DEG
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7277844
• MDR Text Key: 100516161
• Report Number: 1221934-2018-50192
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 228141
• Device Lot Number: L328646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Date Manufacturer Received: 03/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 19 YR