MAUDE Adverse Event Report: PEGA MEDICAL INC THE SIMPLE LOCKING INTRA MEDULLARY (SLIM) SYSTEM; SLIM ROD Ø5.6MMX340MM

Model Number	SLM-56-340
Medical Device Problem Codes	Component Incompatible (1108); Product Quality Problem (1506); Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An old version of the slim nail was used and the information about the sizes of the interlocking holes provided to the company representative was inaccurate.
Event or Problem Description
During a surgery using a ø5.6mmx340mm slim nail, the corresponding peg size did not fit into the distal and proximal holes for fixation.The surgeon decided to use another device for interlocking in this patient.The slim nail used was from a previous version of the nail with smaller interlocking holes.

• Brand Name: THE SIMPLE LOCKING INTRA MEDULLARY (SLIM) SYSTEM
• Common Device Name: SLIM ROD Ø5.6MMX340MM
• Manufacturer (Section D): PEGA MEDICAL INC; 1111 autoroute chomedey,; laval, quebec H7W5J 8; CA H7W5J8
• Manufacturer (Section G): PEGA MEDICAL INC; 1111 autoroute chomedey; laval, quebec H7W5J 8; CA H7W5J8
• Manufacturer Contact: enrique garcia ; 1111 autoroute chomedey,; laval, qiuebec H7W5J-8 ; CA H7W5J8
• MDR Report Key: 15160573
• Report Number: 3000327445-2022-00002
• Device Sequence Number: 5849862
• Product Code: HSB
• UDI-Device Identifier: 07540194003942
• UDI-Public: (01)07540194003942(10)150105-095
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/03/2022

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-56-340
• Device Catalogue Number: SLM-56-340
• Device Lot Number: 150105-095
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown