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

Catalog Number 228143

Device Problem Tip breakage (1638)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/24/2014

Event Type  malfunction  

Event Description

Damaged device + 228141 lot: 3741198 : the needle is on the device.The tip of the gun broke.Recovery inconsequential bits broken.No consequences to the patient.Another like device was used.The following additional information was received from our affiliate on 5-14-14; the tip of the device broke and bits fall into the patient.All the bits were removed.The procedure was completed with another like device.

Manufacturer Narrative

Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy mitek.Depuy mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.In transit.

Manufacturer Narrative

The complaint device was received and evaluated.Visual observation reveals that both the lower and upper pusher rods on the applier are found bent at the distal end, which is typical of aggressively removing the needle following use.No parts of the rods were broken or missing as reported in the complaint, therefore, the complaint cannot be confirmed.The needle that was used in the procedure was also received with the device.Upton inspecting the complaint¿s needle, the needle was observed to be slightly bent sideways causing a distortion in the needle slot.This damage is typical of needle hitting bone or excessive force being applied while using the device.When the applier was tested for its functionality, both triggers functioned properly when pulled on their own without a needle attached to the device.The key feature was examined no anomalies were observed.A 12 degree needle was loaded onto the applier and both implants were deployed successfully, but the grey trigger was rough to operate.A batch record review has been conducted and our results indicate that this batch of product was processed without incident that could cause this failure.Further, a review into the mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.Therefore, no further actions are warranted at this time.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.

Event Description

Damaged device + 228141 lot: 3741198 : the needle is on the device.The tip of the gun broke.Recovery inconsequential bits broken.No consequences to the patient -another like device was used.The following additional information was received from our affiliate on 5-14-14; the tip of the device broke and bits fall into the patient.All the bits were removed.The procedure was completed with another like device.

• Brand Name: MITEK OMNISPAN MENISCAL APPLIER
• Type of Device: ARTHROSCOPIC 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: david primmerman ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 3818664
• MDR Text Key: 4450583
• Report Number: 1221934-2014-00206
• Device Sequence Number: 1
• Product Code: GEF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 228143
• Device Lot Number: 3741209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2014
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/26/2014
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2014
• Date Manufacturer Received: 03/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2013
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1