MAUDE Adverse Event Report: DEPUY MITEK LLC US OMNISPAN MENISCAL REPAIR SYSTEM, W/ 12 DEGREE NEEDLE, EA; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number 228141

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report is being filed from the (b)(4) complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.The batch review 3475214 showed that the devices were conformed to in process and finished goods specifications when released to stock the 16 nov.2010.Expiration date: 2013-10 (according to retained labels).No nc was opened.Ri was opened relating to replacement of mitek hvac motor according to ot with no link with this complaint.Evaluation statement: the complaint device is not being returned, therefore is unavailable for a physical evaluation.A batch record 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 with an unrelated out of tolerance (ot) to the reported incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.We cannot discern a root cause for the reported failure mode.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The sales rep reported that during a mensal repair the implants fell off the needle on the omnispan mensal repair system w/12 degree needle.The sales rep reported that the implants were still tethered to the device and did not come off or fall into the patient.The surgeon completed the procedure with another device with no patient consequences or delay.The sales rep was not present.There is no further information available.The device was already discarded.

• Brand Name: OMNISPAN MENISCAL REPAIR SYSTEM, W/ 12 DEGREE NEEDLE, EA
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7660271
• MDR Text Key: 113337375
• Report Number: 1221934-2018-50967
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705010035
• UDI-Public: 10886705010035
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/06/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2013
• Device Catalogue Number: 228141
• Device Lot Number: 3475214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1