MAUDE Adverse Event Report: DEPUY MITEK LLC US OMNISPAN MENISCAL REPAIR, 0DEG; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 228140

Device Problems Activation, Positioning or Separation Problem (2906); Incomplete or Inadequate Connection (4037)

Patient Problem No Code Available (3191)

Event Date 01/25/2019

Event Type  Injury  

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.Udi: (b)(4).

Event Description

It was reported by the affiliate via email that during an unknown procedure the first implant was positioned correctly in the applicator, but when the doctor used the correct technique (using a malleable hemicanuka) after having crossed the meniscus, the implant would not discharge from the gun despite having repeatedly pressing the trigger.The second implant was positioned correctly in the applicator, but when the doctor used the correct technique (using a malleable hemicanuka) after having crossed the meniscus and fired the first implant, when positioning the second implant a few millimeters, every system came out of the applicator.The surgeon did not want to continue hurting the meniscus with meniscal suture and so chose to do a meniscectomy instead.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the complaint device associated with this complaint was sent to depuy mitek site in raynham, massachusetts on 4/01/19.The tracking number provided shows it was delivered in raynham; however there is no signature of receiving in the complaints group.After repeated attempts to locate the device, it could not be found; therefore, a physical device evaluation cannot be performed.A capa was created to address the systemic issue associated with missing complaint devices at the site and the action was completed on june 27th, 2019.As this complaint falls within this time frame, the corrective action is captured in this capa.If and when the device is located, the complaint will be re-opened to complete the investigation.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.

• Brand Name: OMNISPAN MENISCAL REPAIR, 0DEG
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8473225
• MDR Text Key: 140615678
• Report Number: 1221934-2019-56736
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705010028
• UDI-Public: 10886705010028
• 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: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 228140
• Device Catalogue Number: 228140
• Device Lot Number: L603954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Date Manufacturer Received: 01/28/2020
• Patient Sequence Number: 1