MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC LOW-PRO CORT SCREW 3.5 X 24MM ORTHOLOC SYSTEM; SCREW, FIXATION, BONE

Model Number	58802718
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Nonunion/Delayed-union Bone Fracture (2369); Implant Pain (4561)
Date of Event	01/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the patient presented with pain in the right foot and in the implant.The patient had hardware removed due to mechanical failure/malfunction of fusion( right foot).The initial diagnosis was pseudarthrosis after fusion or arthrodesis.The pre-operative diagnosis was right hallux limitus with non-union.Non-union hallux interphalangeal joint fusion.The patient underwent revision right first metatarsal phalangeal joint fusion.Right foot hardware removal.Right hallux arthroplasty.Calcaneal bone graft harvesting.
Additional Manufacturer Narrative
The reported event could be confirmed based on the operative report of the revision surgery.The device inspection revealed the following: a total of eight (8) devices were returned for evaluation.The devices consisted of one (1) broken plate and seven (7) screws.The broken plate and three (3) of the screws were determined to belong to the variax 2 system.The evaluation of the broken plate and the three (3) screws were performed under complaint pi (b)(4).Visual examination of the other four (4) screws revealed the screws are characteristic of legacy wright medical cannulated screw system (css).Microscopic view of the returned device confirms the lot number and size.The screw head shows signs of wear.No other significant damages are visible on the device.Aside from the signs of wear, the screw is in good condition and there is no indication that the screw contributed to the reported non-union.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that the patient presented with pain in the right foot and in the implant.The patient had hardware removed due to mechanical failure/malfunction of fusion (right foot).The initial diagnosis was pseudarthrosis after fusion or arthrodesis.The pre-operative diagnosis was right hallux limitus with non-union.Non-union hallux interphalangeal joint fusion.The patient underwent revision right first metatarsal phalangeal joint fusion.Right foot hardware removal.Right hallux arthroplasty.Calcaneal bone graft harvesting.

• Brand Name: LOW-PRO CORT SCREW 3.5 X 24MM ORTHOLOC SYSTEM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16362676
• Report Number: 3010667733-2023-00066
• Device Sequence Number: 6814019
• Product Code: HWC
• UDI-Device Identifier: 00840420114006
• UDI-Public: 00840420114006
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K120359
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 58802718
• Device Catalogue Number: 58813524
• Device Lot Number: 2494462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2021
• 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: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic