MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PROBE SAPHYRE 90DEG; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	7209686
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the tip of the cutter head was broken and fall off in the joint cavity when use.The broken part has been removed, resulting in longer surgery operation time.There was no backup device available.No patient injury reported.No significant delay was reported.
Additional Manufacturer Narrative
An evaluation was performed by smith and nephew and could confirm the customer complaint for the tip of the cutter head was broken and fell off.A visual inspection was performed and showed the tip off the device was completely broken off from the shaft of the probe.This damage is caused by contact with another source or excessive force applied to the tip.The investigation identified no cause in the smith and nephew process that can cause or contribute weakening to the device tip.No manufacturing related defects were observed.
Event or Problem Description
It was reported that during an acl reconstruction surgery, the tip of the cutter head was broken and fall off in the joint cavity when use.The broken part has been removed with a curved forceps with the help of the arthroscopy, resulting in longer surgery operation time.A backup device was available to complete the procedure with no patient injuries.

• Brand Name: PROBE SAPHYRE 90DEG
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 8641189
• Report Number: 3003604053-2019-00061
• Device Sequence Number: 1875682
• Product Code: GEI
• UDI-Device Identifier: 03596010470560
• UDI-Public: 03596010470560
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K991218
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 01/02/2021
• Device Catalogue Number: 7209686
• Device Lot Number: 2009171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 05/29/2019; 07/03/2019
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 06/02/2019; 07/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 65