MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,TI,3.5MMX 12MM; PLATE, FIXATION, BONE

Model Number LO-PRO SCRW,TI,3.5MMX 12MM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Fall (1848); Pain (1994)

Event Date 08/08/2018

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The device disposition was unknown by the reporter.The cause of the event could not be determined from the information available and without device evaluation.

Event Description

During social safeguard cyber review (arthrex chatter community) a potential device issue was discovered.Upon further investigation it was confirmed on (b)(6) 2018 that a revision procedure had taken place.Additional information was requested.Additional information obtained 9/5/2018: a patient had a distal radius fracture procedure on (b)(6) 2018.During the procedure the following devices were implanted: ar-8916vnl-03 lot 10183688 (qty 1), ar-8724v-20 (qty 4 lot unknown), ar-8935l12 (qty 1 lot unknown), ar-8935l-14 (qty 1 lot unknown), and ar-8935-12 (qty1 lot unknown).The patient suffered a fall and had a revision procedure on (b)(6) 2018.During the revision procedure all of the original implants were removed and replaced.The following devices were implanted to complete the procedure: ar-8916vnl-03 lot 10189728 (qty1), ar-8724v-18 (qty1 lot unknown), ar-8724v-22 (qty 3 lot unknown), ar-8935l-12 (qty1 lot unknown), ar-8935l-14 (qty 1 lot unknown), and ar-8935-12 (qty1 lot unknown).Per reporter it is unknown when the patients pain began or if patient had any other symptoms prior to the patient's fall.No cultures were taken or any other problems found during revision surgery.The explanted devices are not available to return as the device disposition is unknown by the reporter.

• Brand Name: LO-PRO SCRW,TI,3.5MMX 12MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 7890144
• MDR Text Key: 120827885
• Report Number: 1220246-2018-00656
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888867131934
• UDI-Public: 00888867131934
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• 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,3.5MMX 12MM
• Device Catalogue Number: AR-8935-12
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other