MAUDE Adverse Event Report: SKLAR SURGICAL INSTRUMENTS MAYO-HEGAR NEEDLE DRIVER

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 06/08/2016

Event Type  Injury  

Event Description

Mayo-hegar needle driver broke during use.Needle was being released and metal piece popped off onto mayo stand.Needle driver removed from sterile field and reported an unsafe.Manufacturer: please note that we do not send products to the mfr, but you may arrange for pick-up by calling my number below.

• Brand Name: MAYO-HEGAR NEEDLE DRIVER
• Type of Device: NEEDLE DRIVER
• Manufacturer (Section D): SKLAR SURGICAL INSTRUMENTS; 889 south matlack street; west chester PA 19382
• MDR Report Key: 5778204
• MDR Text Key: 49164191
• Report Number: MW5063281
• Device Sequence Number: 1
• Product Code: KOA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/29/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR