MAUDE Adverse Event Report: DEPUY MITEK MENISCAL APPLIER, OMNISPAN; MENISCAL INSTRUMENT

Catalog Number 228143

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem Surgical procedure, delayed (2565)

Event Date 10/31/2014

Event Type  Injury  

Event Description

The sales rep reported during an acl procedure his omnispan gun locked up after firing the first anchor.It was noticed that the spring was under the needle.When the surgeon tried to remove the gun, the second anchor fell into the joint.The surgeon cut the suture, and removed the first anchor, and also found the second anchor.They opened another like device to complete the procedure.This failure extended the procedure time over 30 minutes.Both devices were discarded by the facility.See associated med watch 1221934-2014-00530.

Manufacturer Narrative

The complaint device is not being returned and therefore an evaluation cannot be performed.Based on the event description provided, an exact root cause for the reported problem cannot be determined.A batch record review has been conducted and the 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 mitek complaints system revealed one other dissimilar complaint for this lot of devices that were released to distribution.Based on the complaint history, at this point in time, no further action is warranted.However, 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: MENISCAL APPLIER, OMNISPAN
• Type of Device: MENISCAL INSTRUMENT
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; quality department; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; na; raynham MA 02767
• Manufacturer Contact: siri belur ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 4285194
• MDR Text Key: 17278543
• Report Number: 1221934-2014-00529
• Device Sequence Number: 1
• Product Code: GEF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: 228143
• Device Lot Number: 3774488
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/31/2014
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2014
• Date Manufacturer Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2014
• 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
• Patient Outcome(s): Other