MAUDE Adverse Event Report: PEGA MEDICAL INC. THE SIMPLE LOCKING INTRA-MEDULLARY (SLIM) SYSTEM; SLIM DRIVER FOR Ø2.0, 2.6 & 3.2 MM RODS

Model Number	SLM-DRV123
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
During a removal procedure of a slim nail, the threads of the driver appeared damage and the surgeon was unable to thread the instrument into the nail.The surgeon had to create another incision and cut the nail out.

• Brand Name: THE SIMPLE LOCKING INTRA-MEDULLARY (SLIM) SYSTEM
• Common Device Name: SLIM DRIVER FOR Ø2.0, 2.6 & 3.2 MM RODS
• Manufacturer (Section D): PEGA MEDICAL INC.; 1111 autoroute chomedey; laval, quebec H7W 5 J8; CA H7W 5J8
• MDR Report Key: 11726660
• Report Number: 3000327445-2021-00004
• Device Sequence Number: 3894709
• Product Code: HXX
• UDI-Device Identifier: 07540194008367
• UDI-Public: (01)07540194008367(10)160421-01
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K192710
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SLM-DRV123
• Device Catalogue Number: SLM-DRV123
• Device Lot Number: 160421-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other