MAUDE Adverse Event Report: PEGA MEDICAL INC. THE SIMPLE LOCKING INTRA-MEDULLARY (SLIM) SYSTEM; SLIM DRIVER FOR Ø4.0, 4.8, 5.6 & 6.4 MM RODS

Catalog Number SLM-DRV146

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 02/12/2021

Event Type  Injury  

Event Description

(b)(4) broke during surgery, the internal shaft came loose from the knob.This was a difficult case due to the implant being buried and having a considerable amount off bone grown over the top of it.The surgeon reamed down to the implant using a large drill bit and able to get the driver on it.When he attached the slap hammer on it pulled the driver apart.

• Brand Name: THE SIMPLE LOCKING INTRA-MEDULLARY (SLIM) SYSTEM
• Type of Device: SLIM DRIVER FOR Ø4.0, 4.8, 5.6 & 6.4 MM RODS
• Manufacturer (Section D): PEGA MEDICAL INC.; 1111 autoroute chomedey; laval, quebec H7W 5 J8; CA H7W 5J8
• Manufacturer (Section G): PEGA MEDICAL INC.; 1111 autoroute chomedey; laval, quebec H7W 5 J8; CA H7W 5J8
• Manufacturer Contact: enrique garcia ; 1111 autoroute chomedey; laval, quebec H7W 5-J8 ; CA H7W 5J8
• MDR Report Key: 11472725
• MDR Text Key: 239397358
• Report Number: 3000327445-2021-00002
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192710
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: SLM-DRV146
• Device Lot Number: 160421-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2021
• Initial Date FDA Received: 03/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1