MAUDE Adverse Event Report: DEPUY MITEK MENISCAL APPLIER, OMNISPAN

Catalog Number 228143

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Code Available (3191)

Event Date 08/17/2015

Event Type  Injury  

Manufacturer Narrative

The complaint device has been received and is currently being investigated.When the evaluation results are available, a follow up medwatch report will be filed.Under investigation.

Event Description

The gray trigger of applicator omnispan not work while using meniscal sutures.The surgeon put the first suture without problems but when tries to place the second suture the gray trigger was loose and did not allow shoot the suture skewered, both products (suture and applicator) are sent for review.Additional information provided by the customer on 9/15/2015 revealed that the procedure was completed by performing partial meniscectomy with a delay of more than 30 minutes.Associated medwatch 1221934-2015-00981.

Manufacturer Narrative

The complaint device was received and evaluated visually and functionally.Visual observations showed the needle was on the applier with only the second implant attached.The first implant was detached but still attached in the suture and needle.The needle was removed and the gray trigger when tested.It was found that the main pusher rod is not under tension.The reported failure can be confirmed.One possible hypothesis would be that during assembly the main rod was not seated correctly, causing the main pusher rod to deploy the implant correctly, but not returning to the original position afterwards.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 without incident.Further, a review into the mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.We believe this issue to be an anomaly and an isolated incident for this lot.We cannot discern a root cause for this issue or determine at what point in time this failure occurred.Based on the overall complaint rate, 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.

Event Description

The gray trigger of applicator omnispan not work while using meniscal sutures.The surgeon put the first suture without problems but when tries to place the second suture the gray trigger was loose and did not allow shoot the suture skewered, both products (suture and applicator) are sent for review additional information provided by the customer on (b)(6) 2015 revealed that the procedure was completed by performing partial meniscectomy with a delay of more than 30 minutes.Associated medwatch 1221934-2015-00981.

• Brand Name: MENISCAL APPLIER, OMNISPAN
• Type of Device: MENISCAL APPLIER
• 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: bahaa nashed ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 5092087
• MDR Text Key: 26348750
• Report Number: 1221934-2015-00982
• Device Sequence Number: 1
• Product Code: GEF
• Combination Product (y/n): N
• Reporter Country Code: PE
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Report Date: 08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 228143
• Device Lot Number: 3833501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2015
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/17/2015
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/17/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2015
• 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; Required Intervention