MAUDE Adverse Event Report: PETER BRASSELER HOLDINGS, LLC BRASSELER USA SURGICAL POWER ACCESSORIES; PIN, FIXATION, SMOOTH

Model Number 5008011M0

Device Problems Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 02/07/2019

Event Type  malfunction  

Event Description

As the surgical tech was opening for a case noted the sterile k-wire had punctured the bottom of the tube it was in which punctured the sterile packaging.K-wire was no longer sterile for use on a patient.

• Brand Name: BRASSELER USA SURGICAL POWER ACCESSORIES
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): PETER BRASSELER HOLDINGS, LLC; 1 brasseler blvd.; savannah GA 31419
• MDR Report Key: 10641910
• MDR Text Key: 210210796
• Report Number: 10641910
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/11/2020,02/08/2019

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: No Information
• Device Model Number: 5008011M0
• Device Catalogue Number: KM172-46-62S
• Device Lot Number: NQ8BK
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/11/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1