MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ELITE PREMIUM COMBINATION GRASPER; ACCESSORIES,ARTHROSCOPIC

Catalog Number	72201181
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 an unknown procedure the device was broken.No back up device was available, no patient injuries or delay were reported.
Additional Manufacturer Narrative
One elite premium combination grasper was returned for evaluation.The device is a reusable instrument and is over nine years old.Visual assessment of the device confirmed the reported complaint of breakage.The handle is heavily corroded at the break area.A device of this age has been subjected to various cleaning processes, sterilization methods, cleaning agents which can play a role in the observed damage.Per the device instruction for use ¿these instruments are designed for repeated use with proper care and handling.Prior to use, inspect the device to ensure it is not damaged.Do not use a damaged device¿.We recommend that all re-usable instruments be routinely inspected for wear/damage and be repaired or replaced as necessary.There are no other complaints for this lot related to this observation.
Event or Problem Description
It was reported that during a shoulder arthroscopy the device broke at the pin axis, and all the pieces were removed from the patient.The procedure was completed with a back up device with no delay or patient injury reported.
Additional Manufacturer Narrative
Examination is not possible, as the device has not been returned, however a photograph was provided.The photograph shows the distal end of the handle has broken off.The break area shows what appears to be corrosion.The device has been in the field for over 9 years without previous issues.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: improper cleaning and sterilization.The instruction for use was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: ELITE PREMIUM COMBINATION GRASPER
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8635693
• Report Number: 1219602-2019-00592
• Device Sequence Number: 13922282
• Product Code: NBH
• UDI-Device Identifier: 03596010594457
• UDI-Public: 03596010594457
• Combination Product (Y/N): N
• Initial Reporter Country: TS
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/21/2019

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: 72201181
• Device Lot Number: 50331500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 06/24/2019; 06/26/2019; 10/18/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 06/24/2019; 06/26/2019; 10/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1