MAUDE Adverse Event Report: DEPUY MITEK TARGET TENDON HARVESTER INSTRUMENTS; ACL INSTRUMENTS

Catalog Number 232004

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/08/2015

Event Type  Injury  

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.Awaiting return.

Event Description

The sales rep reported that during an acl procedure their target tendon harvester was not functioning properly.The sales rep stated that the blade on the device does not retract and no longer going back/forth.The sales rep reported that the surgeon had to cancel the procedure due to the device failure and rescheduled the case.The sales rep reported that the patient was already under anesthesia but had not yet been cut to operate on.The sales rep could not provide a lot number for the device.The device will be returning for evaluation.

Manufacturer Narrative

The complaint device has not been returned, despite requesting for it several times, therefore unavailable for a physical evaluation.One possible hypothesis is that the spring required for the blade to retract was misplaced/lost during sterilization.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.At this point in time, no corrective action is required and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.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

The sales rep reported that during an acl procedure their target tendon harvester was not functioning properly.The sales rep stated that the blade on the device does not retract and no longer going back/forth.The sales rep reported that the surgeon had to cancel the procedure due to the device failure and rescheduled the case.The sales rep reported that the patient was already under anesthesia but had not yet been cut to operate on.The sales rep could not provide a lot number for the device.The device will be returning for evaluation.

• Brand Name: TARGET TENDON HARVESTER INSTRUMENTS
• Type of Device: ACL INSTRUMENTS
• 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: 5131087
• MDR Text Key: 27643640
• Report Number: 1221934-2015-00994
• Device Sequence Number: 1
• Product Code: NBH
• 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: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 232004
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/08/2015
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2015
• Date Manufacturer Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1