MAUDE Adverse Event Report: SKLAR CORPORATION KELLY CLAMP; FORCEPS, GENERAL & PLASTIC SURGERY

Device Problem Break (1069)

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

Event Date 05/09/2022

Event Type  malfunction  

Event Description

Curved kelly clamp broke at the top of the clamp below the scissor joint.The whole one side of the jaw broke off, outside of the patient.

• Brand Name: KELLY CLAMP
• Type of Device: FORCEPS, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SKLAR CORPORATION; 1333 lenape rd.; west chester PA 19382
• MDR Report Key: 14436057
• MDR Text Key: 292040021
• Report Number: 14436057
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/10/2022

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
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/10/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14965 DA
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Race: White