MAUDE Adverse Event Report: SMITH & NEPHEW, INC. O*REFURB,SMALL JOINT GRASPER; ACCESSORIES,ARTHROSCOPIC

Catalog Number 013219D

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/28/2024

Event Type  malfunction  

Event Description

It was reported that during wrist arthroscopy, the small joint grasper (b)(4) clamp broke inside the cavity when being used to remove the entire screw, when forcefully used, the tip was broken.The screw did not break.It is unknown how the procedure was completed.There was a delay greater than 30 minutes.No further complications were reported.

Manufacturer Narrative

Internal complaint reference: (b)(4).

• Type of Device: 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 drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19149832
• MDR Text Key: 341026752
• Report Number: 1219602-2024-00845
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00885556604540
• UDI-Public: 00885556604540
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 013219D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/20/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Sex: Male