MAUDE Adverse Event Report: DEPUY MITEK MITEK CORD CUTTER; ARTHROSCOPIC SUTURE CUTTER

Catalog Number 214646

Device Problem Tip breakage (1638)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2014

Event Type  malfunction  

Event Description

The sales rep reported that during a shoulder repair, the metal tip broke off his cord cutter inside the patient's joint space.The surgeon retrieved it and no x-rays where needed.The surgeon was cutting the last suture when the device broke.The surgeon completed the procedure with no patient consequences or delays.The sales rep reported the device did not hit bone.The sales rep could not provide a lot number but reported that the device was about 8 years old and had not seen heavy use.The device is being returned for evaluation.The lot number of the complaint device was confirmed to be 12k08 at the time the device was received by mitek complaints on (b)(4) 2014.

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 however it is not known if it will be received within the 30 day reporting requirement, therefore 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.

Manufacturer Narrative

The complaint device was received and evaluated.The returned device shows no anomalies and is fully intact.The device is not broken as reported.Follow up with the sales rep regarding the complaint device did not yield any further information.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 depuy mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.At this point in time, this complaint cannot be confirmed or a root cause for the user to have experienced the reported failure cannot be discerned.No further action is warranted.However, should additional information be provided to mitek at any time in future, this complaint will be re-opened and appropriate actions will be taken.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.

Event Description

The sales rep reported that during a shoulder repair, the metal tip broke off his cord cutter inside the patient's joint space.The surgeon retrieved it and no x-rays where needed.The surgeon was cutting the last suture when the device broke.The surgeon completed the procedure with no patient consequences or delays.The sales rep reported the device did not hit bone.The sales rep could not provide a lot number but reported that the device was about 8 years old and had not seen heavy use.The device is being returned for evaluation.The lot number of the complaint device was confirmed to be 12k08 at the time the device was received by mitek complaints on april 9, 2014.

• Brand Name: MITEK CORD CUTTER
• Type of Device: ARTHROSCOPIC SUTURE CUTTER
• 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: 3772920
• MDR Text Key: 4376129
• Report Number: 1221934-2014-00158
• 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,Followup
• Report Date: 03/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 214646
• Device Lot Number: 12K08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2014
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/28/2014
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2014
• Date Manufacturer Received: 03/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1