MAUDE Adverse Event Report: RESOLVE SURGICAL TECHNOLOGIES 1.7MM CABLE WITH CRIMP 750MM-STERILE; CERCLAGE, FIXATION

Model Number	298.801.01S
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2022 the surgeon removed a va condylar femur plate and 6.5 cannulated screw along with a stryker gamma nail in order to perform a distal femur replacement at a future date.The va condylar plate was used to treat a femur fracture on (b)(6) 2022.No further information is available.This report is for a 1.7mm cable with crimp 750mm-sterile this is report 1 of 1 for (b)(6).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.The picture was returned to depuy synthes for evaluation.The depuy synthes team forwarded the picture to the supplier which conducted a visual inspection of the returned image.Inspection results for this device are as follows: based off the photos provided it appears that the cable was not tensioned fully.Without the device a definitive root cause cannot be determined with the information provided.A dhr review could not be completed because the device was not returned and sufficient information was not provided.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the 1.7mm cable with crimp 750mm there is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 1.7MM CABLE WITH CRIMP 750MM-STERILE
• Common Device Name: CERCLAGE, FIXATION
• Manufacturer (Section D): RESOLVE SURGICAL TECHNOLOGIES; 375 river park circle; marquette MI 49855
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16264348
• Report Number: 1833824-2023-00010
• Device Sequence Number: 4386183
• Product Code: JDQ
• UDI-Device Identifier: 10886982182500
• UDI-Public: (01)10886982182500
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K992616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 298.801.01S
• Device Catalogue Number: 298.801.01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 01/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4.5 VA-LCP CRVD COND PL/10 HOLE/230/LFT; 5.0MM VA POSITIONING PIN; UNK - SCREWS: 6.5 MM CANNULATED
• Patient Age: 70 YR
• Patient Sex: Female