MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GRASPER ALLIGATOR MAX EXTENDED; ACCESSORIES,ARTHROSCOPIC

Model Number	7207699
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that the grasper alligator max was broken into two parts.It is unknown whether the event happened during the arthroscopy and if there was patient involvement.It is unknown if there was a delay or if a backup device was available and how the issue was resolved.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed that the device had separated into three pieces because the set screw was missing.There was some wear on the device but no other visual issues.A review of the device records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.The complaint was confirmed and the root cause was associated with maintenance.Factors that could have contributed to the reported event include repeatedly rough sterilization processes or lack of functional tests after sterilization to verify complete assembly.No containment or corrective actions are recommended at this time.

• Brand Name: GRASPER ALLIGATOR MAX EXTENDED
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11499064
• Report Number: 1219602-2021-00540
• Device Sequence Number: 4497602
• Product Code: NBH
• UDI-Device Identifier: 03596010462923
• UDI-Public: 03596010462923
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/27/2021

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: 7207699
• Device Catalogue Number: 7207699
• Device Lot Number: 50854893
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1