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

Catalog Number 228141

Device Problems Detachment Of Device Component (1104); Operating System Becomes Nonfunctional (2996)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/16/2018

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4) ¿ incomplete.The expiration date is not currently available.

Event Description

Casing damaged.The white casing is broken which lead to two baffles to fall off automatically and can not be used any more during in the meniscus prosthesis surgery.Changed another one to complete.Enclosed please find the defect photos.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The complaint device was received and inspected.The complaint can be confirmed.It was observed that the casing which holds the implants on the needle was broken, and the implants were still attached to the needle via the orthocord.One of the implants appeared to be previously deployed.When the needle is inserted too forcefully into the tissue or at a depth that is too deep, the casing that holds the implants may be damaged therefore is a potential root cause for the reported failure.However, given the information provided we cannot discern a definite root cause for the reported failure.A device history record (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; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.At this point, 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).

• 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: 7434609
• MDR Text Key: 106034536
• Report Number: 1221934-2018-50472
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705010035
• UDI-Public: 10886705010035
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 228141
• Device Lot Number: L374377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2018
• Date Manufacturer Received: 05/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 92