MAUDE Adverse Event Report: ARTHROCARE CORP. NEEDLE AND SUTURE CAPTURE; ACCESSORIES,ARTHROSCOPIC

Catalog Number 22-4036

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during a shoulder procedure, the top jaw fell off needle capture once loaded.It is unknown if the pieces were removed from the patient and if there was a delay or a backup device available to complete the procedure.There were no patient injuries reported and attempts were made to retrieve further information but no response has been received from the complainant.

Event Description

It was reported that during a shoulder procedure, the top jaw fell off needle capture once loaded.It is unknown if the pieces were removed from the patient.There was no significant delay or patient injuries and the procedure was completed but it is unknown what type of device was used.Complainant does not have further information.

Manufacturer Narrative

The reported disposable firstpass suture passer device, intended for use in treatment, was not returned for evaluation.A relationship between the product and reported incident cannot be established as the product was not returned.Without the reported product a visual and functional evaluation cannot be performed and customer¿s complaint cannot be confirmed.From the information provided, ¿during a shoulder procedure, the top jaw fell off needle capture once loaded.¿ an exact root cause cannot be determined without evaluation of the device; however, factors unrelated to the manufacture or design of the device that could have contributed to the reported event include: (1) incorrect suture trap loading (2) excessive force (3) incorrect device disassembly.Use of other suture is not recommended and may compromise device performance.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: NEEDLE AND SUTURE CAPTURE
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8634358
• MDR Text Key: 146053314
• Report Number: 3006524618-2019-00248
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00817470000184
• UDI-Public: 00817470000184
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/04/2019

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: 22-4036
• Device Lot Number: 2013526
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/03/2019
• Initial Date FDA Received: 05/22/2019
• Supplement Dates Manufacturer Received: 05/22/2019; 07/03/2019
• Supplement Dates FDA Received: 05/28/2019; 07/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1