MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PCH BSKT RTRY 90D 2.2MM RT.LP; ACCESSORIES,ARTHROSCOPIC

Model Number	010913
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that corrosion was detected during arthroscopic surgery.Meniseectomy.No patient injury was reported.No back up available.
Additional Manufacturer Narrative
Due to no product return, the complaint could not be confirmed.Definitive conclusions cannot be made without a device to evaluate.Accurate investigation and evaluation are not possible.A review of the device history record shows there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.
Event or Problem Description
It was reported that corrosion was detected during arthroscopic meniscectomy.No backup device was readily available.Despite several attempts to get further information regarding completion of the device or surgical delay, no response was received.No patient injury was reported.

• Brand Name: PCH BSKT RTRY 90D 2.2MM RT.LP
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7313353
• Report Number: 1219602-2018-00286
• Device Sequence Number: 110463
• Product Code: NBH
• UDI-Device Identifier: 03596010022813
• UDI-Public: (01)03596010022813(10)L839017
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2018

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
• Operator of Device: Health Professional
• Device Model Number: 010913
• Device Catalogue Number: 010913
• Device Lot Number: L839017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/06/2018
• Supplement Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 03/05/2018
• Supplement Report FDA Received Date: 03/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1