MAUDE Adverse Event Report: RESOLVE SURGICAL TECHNOLOGIES CABLE TENSIONER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	391.201
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes (b)(4) reports an event as follows: the golden handle cable tensioner does not rise up to the limit of the tension line; its gives tension, but it does not mark.In surgery the cable did have good tension.There was no impact to the patient, the surgical time was not prolonged.This report is for a cable tensioner.This is report 1 of 1 for pc-(b)(4).
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter is a synthes employee 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.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.
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.H6 investigation summary: the product was returned to depuy synthes for evaluation.The depuy synthes team forwarded the device to resolve surgical which conducted a visual inspection of the returned device.Additionally, the provided image under pc attachment was reviewed for investigation.Visual analysis of the returned sample was performed on cable tensioner.This device was tested per procedure and it was found that the tensioner does not engage the cable.Due to this fact, the device was not able to generate any tension on the cable.Root cause of this failure was not able to be identified at this time, however the epoxy from the set screw on the tensioning knob is not present indicating that the tensioner was possibly disassembled at some point in the past.Upon disassembly of the device it was visually confirmed by assembly operator and ivs qe that there was no damage to lower level components.The lower level collet tips (400-847) which are critical to the function of this device passed inspection using digital overlay using digital overlay gage id 3534.Belleville washer stack was intact with no visual damage.The dimensional inspection was not performed due to complex geometry of the device.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the cable tensioner.The received condition of the cable tensioner confirmed that the device was not able to generate any tension on the cable.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.Drawing/specifications reviewed: no issues.Device history: part # 391.201; lot # p253590; manufacturing site: werk selzach; release to warehouse date: 06 oct2016.Supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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: CABLE TENSIONER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): RESOLVE SURGICAL TECHNOLOGIES; 375 river park circle; marquette MI 49855
• Manufacturer (Section G): RESOLVE SURGICAL TECHNOLOGIES; 375 river park circle; marquette MI 49855
• Manufacturer Contact: brandee sandy ; 375 river park circle; marquette, MI 49855
• MDR Report Key: 13834942
• Report Number: 1833824-2022-00022
• Device Sequence Number: 1545619
• Product Code: LXH
• UDI-Device Identifier: 07611819719811
• UDI-Public: (01)07611819719811
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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 Catalogue Number: 391.201
• Device Lot Number: P253590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/19/2022
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 03/20/2022
• Supplement Report FDA Received Date: 05/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown