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
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/11/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8381720
• Report Number: 1220246-2019-00927
• Device Sequence Number: 1163170
• Product Code: HRS
• UDI-Device Identifier: 00888867049697
• UDI-Public: 00888867049697
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K150456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2019

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: 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
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 03/07/2019
• 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