MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY PIONEER SURGICAL TECHNOLOGIES ORTHOPEDIC CABLE SYSTEM CERCLAGE; ORTHOPEDIC FIXATION CERCLAGE

Model Number	400-798
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	07/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Resolve surgical was not made aware of this incident until (b)(6) 2023, two full years after the revision.Multiple attempts have been made to get more information from depuy synthes on why there was such a large gap in time for awareness, but no infomation has been given as of now.Should more information become available at a later date, a follow up report will be filed.Device not available for inspection due to patient retention.Manufacturing records were reviewed and found the product to meet specifications before leaving resolve surgical.
Event or Problem Description
Dps emailed a complaint form on (b)(6) 2023 for an incident that happened in 2021, "on (b)(6) 2021, the patient underwent left total knee arthroplasty with distal replacement.Hardware removal left femur due to left supracondylar/intercondylar femoral fracture nonunion, hardware failure and osteoarthritis left knee.It was reported that on (b)(6) 2021, the patient had a fall.She was climbing over like a dog gate, tripped and fell.She initially felt pain in her left knee.She was diagnosed with a left distal femur fracture.On (b)(6) 2021 the patient underwent left distal femur open reduction and internal fixation with a synthes latreral plate and multiple cerclage cables due to left distal femur comminuted intra-articular fracture and morbid obesity.This complaint involves eighteen (18) devices." only 3 of the devices are from resolve surgical.

• Brand Name: PIONEER SURGICAL TECHNOLOGIES ORTHOPEDIC CABLE SYSTEM CERCLAGE
• Common Device Name: ORTHOPEDIC FIXATION CERCLAGE
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY; 357 river park circle; marquette MI 49855
• Manufacturer (Section G): PIONEER SURGICAL TECHNOLOGY; 357 river park circle; marquette MI 49855
• Manufacturer Contact: cassy baij ; 357 river park circle; marquette, MI 49855 ; 9062269909
• MDR Report Key: 17383625
• Report Number: 1833824-2023-00091
• Device Sequence Number: 6072397
• Product Code: JDQ
• UDI-Device Identifier: 10886982182500
• UDI-Public: (01)10886982182500(17)250831(10)P376354
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K992616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: 400-798
• Device Lot Number: P376354
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2020
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown