MAUDE Adverse Event Report: RESOLVE SURGICAL TECHNOLOGIES Ø1.7MM CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	03.221.017
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from the united kingdom reports an event as follows: it was reported that on an unknown date, the lock on the cable system broke.Procedure was completed with no delay.There was no patient harm.This report is for a ø1.7mm cable lock for pistol grip cable tensioner.This is report 1 of 1 for (b)(4).
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.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.H10 additional narrative: h3, h4, h6 investigation summary note: following investigation was performed by the supplier.Although distributed by depuy synthes, the product is designed, manufactured, and labeled by the manufacturing supplier.The requirement of fda reporting, complaint investigation, root cause, and corrective action is the responsibility of the designing supplier of this item, per the supplier agreement.The product/information will be transferred to the supplier with the complaint problem statement for investigation.The results of the supplier investigation are to be populated into the depuy synthes customer quality complaint management system.Per the supplier agreement, the supplier is responsible for any corrective actions identified during the complaint investigation process.The product was returned to depuy synthes for evaluation.The depuy synthes team forwarded the device to the supplier which conducted a visual inspection of the returned device.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for the device 03.221.017, cable lock ø1.7 f/cable tensioner one-h+.Device was returned to supplier on: 1/17/2023 inspection results for this device are as follows: upon initial visual inspection it was found that there is no major physical damage to the instrument with only minimal signs of use, which include some light galling of the cam feature on the lever.Device was tested per routing text for operation 0030 assy, which states, "test assembly minimum holding ability assemble bit assembly on tensioner and tension to 50kg mark and verify that cable does not slip".Per this routing text, the device passes this inspection.A dhr review was completed and the device was manufactured to specifications prior to shipping.This complaint will be logged for trending purposes.No further actions will be taken at this time.Device passed inspections.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 history part # 03.221.017 synthes lot # p39967 supplier lot # p39967 release to warehouse date # 16 sep 2021 supplier # rti surgical no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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: Ø1.7MM CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): RESOLVE SURGICAL TECHNOLOGIES; 375 river park circle; marquette MI 49855
• Manufacturer Contact: brandee sandy ; 375 river park circle; marquette, MI 49855
• MDR Report Key: 15734134
• Report Number: 1833824-2022-00162
• Device Sequence Number: 6316607
• Product Code: LXH
• UDI-Device Identifier: 07611819500075
• UDI-Public: (01)07611819500075
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: 03.221.017
• Device Lot Number: P39967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2022
• Supplement Date Received by Manufacturer: 01/14/2023; 02/17/2023
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 02/13/2023; 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2021
• 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