MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MTO,KNOT MANIPULATOR, SHORT,SEE 72201213; ACCESSORIES,ARTHROSCOPIC

Catalog Number 72201027

Device Problem Device Damaged by Another Device (2915)

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

Event Date 07/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the knot pushers damaging the anchor wire.A competitors device was used to complete the surgery.There was it was reported the knot pushers damaging the anchor wire.A competitors device was used to complete the surgery.There were no patient injuries reported.

Manufacturer Narrative

Device investigation narrative - visual inspection and functional testing could not be performed because the device in question was not returned for evaluation.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.There are no indications that would suggest that the device did not meet product specifications upon release into distribution.Evaluation codes updated.

• Brand Name: MTO,KNOT MANIPULATOR, SHORT,SEE 72201213
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 6788390
• MDR Text Key: 82676567
• Report Number: 1219602-2017-00908
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72201027
• Device Lot Number: 50656630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/14/2017
• Initial Date FDA Received: 08/11/2017
• Supplement Dates Manufacturer Received: 07/14/2017
• Supplement Dates FDA Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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