MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY, INC. SDB CERCLAGE SYSTEM; CERCLAGE, FIXATION

Catalog Number	298.801.01S-US
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Limb Pain (4836)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Product was not returned.A device history record review cannot be completed as a batch number for the device was not provided.Based on the lack of information provided regarding this complaint, a root cause determination cannot be made.Should additional information be provided that aids in the investigation of this complaint, the complaint will be reopened.
Event or Problem Description
Complaint received for patient with periprosthetic fracture that underwent surgery.Surgeon reported that the patient healed nicely.Postoperatively, one of the cables broke and was prominent in patient's deep soft tissue causing pain in the middle third of the thigh.Removal of the hardware was successfully completed without any intraoperative or postoperative complications.

• Brand Name: SDB CERCLAGE SYSTEM
• Common Device Name: CERCLAGE, FIXATION
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY, INC.; 375 river park circle; marquette MI 49855
• Manufacturer (Section G): PIONEER SURGICAL TECHNOLOGY, INC.; 375 river park circle; marquette MI 49855
• Manufacturer Contact: 375 river park circle; marquette, MI 49855
• MDR Report Key: 20224930
• Report Number: 1833824-2024-41702
• Device Sequence Number: 3469490
• Product Code: JDQ
• UDI-Device Identifier: 10886982182500
• UDI-Public: 10886982182500
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K992616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/11/2024

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 Catalogue Number: 298.801.01S-US
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown