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

Catalog Number	010912
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a knee arthroscopy the device did not open.The procedure was completed with another similar device.No significant delay or patient injury reported.
Additional Manufacturer Narrative
Foreign post code - (b)(6).One rotary 90 degree 3.4mm left punch basket instrument returned.This is a six year old reusable instrument.The complaint stated: "it was reported that, during a knee arthroscopy, the device did not open.¿ the cutting edges meet tightly when closed.There was no damage observed.As received, the articulating jaw component was stuck in the closed position.Obvious bio remains and possible rusting of the cutting area were observed.The instrument has not been cleaned properly or allowed to dry thoroughly.This may contribute to the jammed jaw.Adjustment of the scissor action may be required.No root cause related to the manufacturing of this device was confirmed.
Event or Problem Description
It was reported that, during a knee arthroscopy, the device did not open.The procedure was completed with a device from the competence.No delay or patient injury reported.

• Brand Name: PCH BSKT RTRY 90D 2.2MM L LP
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8307854
• Report Number: 1219602-2019-00139
• Device Sequence Number: 2119995
• Product Code: NBH
• UDI-Device Identifier: 03596010022776
• UDI-Public: 03596010022776
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 010912
• Device Lot Number: LT113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1