MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GRSPR D/A ATRAUMATIC 5MMX36CM; ACCESSORIES,ARTHROSCOPIC

Catalog Number 8360-10

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 01/01/1901

Event Type  malfunction  

Manufacturer Narrative

Device investigation narrative - visual assessment of the device confirmed the reported complaint of disassembly.The dual action links have come free from the assembly.Only one of the two links were returned for evaluation.The returned link is well worn were it interfaces with the actuator.Shrink tubing has been applied to the sheath.The sheath is also slightly bowed.The device has been repaired as the handle has been bead blasted and has had additional etching (aes 10/16, s) added.The devices jaws have not been finished properly during the repair as they have multiple sharp edges that could cause injury during use.The condition of the device indicates the repair of the device likely contributed to the reported failure.Further investigation is not warranted at this time.(b)(4).

Event Description

It was reported the spring broke off the grasper.It is unknown if a backup device was available.There was a delay of less then 30 minutes.No patient injuries were reported.

• Brand Name: GRSPR D/A ATRAUMATIC 5MMX36CM
• 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: 6788386
• MDR Text Key: 82671491
• Report Number: 1219602-2017-00913
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/11/2017

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: 8360-10
• Device Lot Number: 50244650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2017
• Initial Date FDA Received: 08/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2008
• 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