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

Model Number	391.201
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that in sterile processing on an unknown date, a cable tensioner had a cable stuck in it.There was no patient involvement.This report is for a cable tensioner.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Date of event is an unknown date in 2022.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
Date of event is an unknown date in 2022.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.
Event or Problem Description
It was reported that in sterile processing on an unknown date, a cable tensioner had a cable stuck in it.There was no patient involvement.This report is for a cable tensioner.This is report 1 of 2 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.H10 additional narrative: h3, h6: part: 391.201.Synthes lot: p049357.Supplier lot: n/a.Release to warehouse date: october 08, 2009.Expiration date: n/a.Supplier: pioneer surgical technology.No nonconformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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.Visual analysis of the returned sample was performed on cable tensioner.Through a visual investigation, stuck cable segment was removed from device, however several small fragments of cable are still lodged in the collet tip area of the tensioner in a way that does not allow a cable to be passed through the device.Due to these cable fragments, the device could not be tested.It was noted that the device operates smoothly and visually it appears that the collet tips move from the full open position to the closed position normally.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 fragments of cable lodged in the collet tip area of the tensioner does not allow a cable to be passed through the device.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: CABLE TENSIONER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): RESOLVE SURGICAL TECHNOLOGIES; 375 river park circle; marquette MI 49855
• Manufacturer Contact: dan nelson ; 375 river park circle; marquette, MI 49855
• MDR Report Key: 13441201
• Report Number: 1833824-2022-00010
• Device Sequence Number: 2045631
• Product Code: LXH
• UDI-Device Identifier: 10886982198204
• UDI-Public: (01)10886982198204
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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: 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 Model Number: 391.201
• Device Catalogue Number: 391.201
• Device Lot Number: P049357
• 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: 01/06/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2009
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK - CABLE/WIRE
• Patient Sex: Unknown