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

Model Number	03.221.015
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.Complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was conducted: part # 03.221.015, synthes lot # p246799, supplier lot # p246799.Release to warehouse date: 20 aug 2016.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.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 during device inspection it was identified that the cable tensioner releases the cable after tightening.It works initially but then the cable slips.There was no patient involvement.This report is for one (1) cable tensioner with pistol grip.This is report 1 of 1 for complaint (b)(4).

• Brand Name: CABLE TENSIONER WITH PISTOL GRIP
• 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 ; 9062269909
• MDR Report Key: 15086846
• Report Number: 1833824-2022-00059
• Device Sequence Number: 17433701
• Product Code: LXH
• UDI-Device Identifier: 10886982076748
• UDI-Public: (01)10886982076748
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: 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: 03.221.015
• Device Catalogue Number: 03.221.015
• Device Lot Number: P246799
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2016
• 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