MAUDE Adverse Event Report: KINAMED, INC. SUPERCABLE ISO-ELASTIC CERCLAGE SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	35-800-2020
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	06/03/2025
Type of Reportable Event	Death
Event or Problem Description
Reporter's own words: straight tensioner [35-800-2020] was broken before the start of the case.The deployment post was bent so unusable.We then had to use the angled tensioner which is difficult to use and not ideal.In the middle of the case it [assumed to refer to 35-800-7000] fell apart.We then had to put it back together enough so we could use it to complete the case.In total i [reporter] feel it added an hour at least to a very difficult procedure.Patient was elderly and unwell so time is important to get him out of theatre as quickly as possible.Patient has a peri prosthetic fracture that needed to be repaired.As the surgeon was applying staples to close the wound at the end of the case, the patient's cardiac status became unstable.The total operation was long and complex, took about 5 hours and involved removal of a cemented stem and implantation of a revision stem.Subsequent report from distributor: elderly patient underwent femoral peri-prosthetic fracture repair procedure using cable fixation, plate, and hip stem.During the procedure there was a delay of approximately 60 minutes due to instrument malfunction.The repair was completed and during closure, the patient went into cardiac arrest and passed away some time after the procedure.To date, over 240,000 supercable cerclage implants have been used in approximately 48,000 surgeries since introduction in 2004.This is the first report of this type received from all post-market surveillance activities involving the supercable system.The incidence rate for this type of event is 0.002% (1 out of 48,000).A literature search (citations referenced below) was conducted to determine the mortality rate during and following revision total hip arthroplasty (tha) performed for periprosthetic fracture.The mortality rate reported in the literature is substantially higher than the rate associated with the supercable system.Berstock et al [1] reviewed 32 studies involving over 1 million patients and reported a mortality rate of 0.30% during the first 30 days following hip replacement.They found that the most common risk factors for early mortality were increasing age, male gender, and co-morbid conditions such as cardiovascular disease.They reported that the 30-day mortality for the > 80 age group was 1.43%.Haughom et al [2] reviewed 523 periprosthetic hip fracture cases and found that 14.5% of the patients experienced a severe adverse event, and that the 30-day mortality rate was 2.7%.They reported that age greater than 85 was an independent risk factor for mortality following periprosthetic fracture.Karlidag et al [3] reviewed 13,203 revision total hip arthroplasty cases and reported a 0.53% mortality rate (70 patients) during hospitalization.Khan et al [4] reviewed 6,131 revisions performed for periprosthetic fracture and reported that the probability of death in males over 75 years with asa class >= 3 (asa class is a measure of co-morbidity) was approximately 9% at 90 days.Lamb et al [5] reported an inpatient mortality rate of 2.4% based on data from 10 studies that included 1293 patients with mean age of 76.3 years.Laughlin et al [6] reviewed 596 revision tha cases and reported a 30-day mortality rate of 0.34%.They found that patients with a periprosthetic fracture had a higher risk of death compared to all other indications for revision tha, and that increased age at the time of revision tha and male gender were associated with a higher risk of death.

• Brand Name: SUPERCABLE ISO-ELASTIC CERCLAGE SYSTEM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): KINAMED, INC.; 820 flynn road; camarillo CA 93012 8701
• Manufacturer (Section G): KINAMED, INC.; 820 flynn road; camarillo CA 93012 8701
• Manufacturer Contact: tina reigelman ; 820 flynn road; camarillo, CA 93012-8701 ; 8053842748
• MDR Report Key: 22329669
• Report Number: 2027148-2025-00002
• Device Sequence Number: 9436656
• Product Code: LXH
• UDI-Device Identifier: 00818720011363
• UDI-Public: (01)00818720011363
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: 510(K)EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2025

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: 35-800-2020
• Device Catalogue Number: 35-800-2020
• Device Lot Number: K19180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Death
• Patient Age: 88 YR
• Patient Sex: Male