MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,TI,3.0MMX 28MMCORT; PLATE, FIXATION, BONE

Model Number LO-PRO SCRW,TI,3.0MMX 28MMCORT

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/11/2019

Event Type  Injury  

Manufacturer Narrative

The device was received but has not yet been evaluated.Once evaluated, a supplemental report will be submitted.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported that two screws broke during a lisfranc procedure.The first screw ar-8740-52pts broke in half when spanning between the first metatarsal and the second metatarsal.Both broken pieces were removed from the patient.The second screw that broke was an ar-8933-28 which was being used in the plate.The head broke off the screw; the remainder of the screw remains in the patient.

Manufacturer Narrative

Complaint was confirmed.A fracture was observed on the underside of the screw.A critical dimensional measurement was done on the returned device.The device met all specifications as received.The most likely cause for this event to have occurred is by over torqueing the screw when inserting into the plate and hard bone.

• Brand Name: LO-PRO SCRW,TI,3.0MMX 28MMCORT
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8381720
• MDR Text Key: 137522411
• Report Number: 1220246-2019-00927
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888867049697
• UDI-Public: 00888867049697
• Combination Product (y/n): N
• PMA/PMN Number: K150456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LO-PRO SCRW,TI,3.0MMX 28MMCORT
• Device Catalogue Number: AR-8933-28
• Device Lot Number: 1003049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Date Manufacturer Received: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other