MAUDE Adverse Event Report: RTI SURGICAL CABLE TENSIONER WITH PISTOL GRIP; MISC ORTHO SURGICAL INSTR

Model Number	03.221.015
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed, no product was received; 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.
Event or Problem Description
It was reported that on an unknown date, both cable tensioner with pistol grip was unable to hold the cable within its construct once fully tensioned.Cables would continuously slide through the tensioner preventing the final tension from being reached.It was unknown when the issue was discovered.Patient and procedure involvement are unknown.Concomitant device reported: unknown cables (part# unknown, lot# unknown, quantity unknown).This complaint involves two (2) devices.
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.H10 additional narrative: h3, h4, h6- product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot : part # 03.221.015.Synthes lot # p094631.Supplier lot # p094631.Release to warehouse date: 18 may 2011.Supplier: (b)(4).No ncr's were generated during production.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 further reported that the reported issues was discovered during surgery and after the surgery was completed after going through sterilization.The cable kept slipping during a case.No harm was done to the patient during the procedure.
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.H10 additional narrative: b5; d7a; g1 h3, h6: a product investigation was conducted.Service and repair evaluation: the customer reported 03.221.015, cable tensioner with pistol grip was unable to hold the cable within its construct once fully tensioned, cables would continuously slide through the tensioner preventing the final tension from being reached.The repair technician reported the device required further testing at the vendor.The cause of the issue is not determined.The vendor reported that the device had passed the functional inspection.Vendor also reported that the device was tested using test stand tensioning bit, as the complaint device was not sent back to vendor with the tensioning bit which was used at the time of failure.The item will be repaired per the inspection sheet and will be returned to the customer upon completion of the service and repair process.The evaluation was unconfirmed.The device was deemed serviceable and will be returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.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.D9; g1.

• Brand Name: CABLE TENSIONER WITH PISTOL GRIP
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): RTI SURGICAL; 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 ; 6107195000
• MDR Report Key: 13214159
• Report Number: 1833824-2022-00004
• Device Sequence Number: 2214778
• Product Code: LXH
• UDI-Device Identifier: 10886982076748
• UDI-Public: (01)10886982076748
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,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 Model Number: 03.221.015
• Device Catalogue Number: 03.221.015
• Device Lot Number: P094631
• 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: 12/14/2021
• Supplement Date Received by Manufacturer: 06/03/2022; 06/03/2022
• Initial Report FDA Received Date: 01/10/2022
• Supplement Report FDA Received Date: 02/08/2022; 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2011
• 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: CABLE TENSIONER WITH PISTOL GRIP; UNK - CABLE/WIRE
• Patient Sex: Unknown