MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL VAS 2.7X30 DEG SH; ARTHROSCOPE

Catalog Number 4131S

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 08/14/2020

Event Type  malfunction  

Manufacturer Narrative

Device currently under investigation by the manufacturing registered site.

Event Description

It was reported that the scope is bent.No case reported; therefore, there was no patient involvement.Preliminary results of investigation have concluded that the scope had a cracked distal lens which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H2, h3, h6.The device, which was not used in a procedure, was returned for evaluation.There was a relationship between the reported event and the device.A visual inspection was performed and showed the scope to have distal tip and fiber damage, a badly bent outertube and a cracked distal lens.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be trended to assess for any necessary corrective actions.This failure is confirmed not originate from manufacturing, packaging, or labeling defects.No manufacturing related defects were observed.

• Brand Name: SVCE REPL VAS 2.7X30 DEG SH
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 10694678
• MDR Text Key: 211888853
• Report Number: 3003604053-2020-00129
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• PMA/PMN Number: K971253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/19/2020

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: 4131S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/17/2020
• Supplement Dates Manufacturer Received: 09/23/2020
• Supplement Dates FDA Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1