MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GRSPR CUPD 3.4MM; ACCESSORIES,ARTHROSCOPIC

Model Number	011014
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a shoulder arthroscopy, the grasper device was not grasping tightly, the instrument was broken.The procedure was successfully completed without delay using a back-up device.No other complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.It was determined the device did not contribute to the reported event.A complaint history review found similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest that the anticipated risk region is not adequate.A visual inspection of the returned device found that it is not in its original packaging.The markings on the device confirm the part number, and are very worn.The device overall is very worn from use.The top jaw of the device is slightly offset and bent to the side.A functional evaluation of the device found that it actuates freely and without resistance.The device does not hold the testing material securely due to the bend of the jaw.The complaint was confirmed, and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an impact event inconsistent with normal use.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: GRSPR CUPD 3.4MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon driv; austin, TX 78735 ; 5123913905
• MDR Report Key: 13585481
• Report Number: 1219602-2022-00274
• Device Sequence Number: 4533150
• Product Code: NBH
• UDI-Device Identifier: 03596010022936
• UDI-Public: 03596010022936
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2022

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: 011014
• Device Catalogue Number: 011014
• Device Lot Number: 50580567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown