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

Model Number	03.221.015
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.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, the cable tensioner with pistol grip was broken.The issue was discovered in the field inventory.No patient involvement.This report is for one (1) cable tensioner with pistol grip.This is report 1 of 1 for complaint (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.H6: part #: 03.221.015.Synthes lot #: p276230.Supplier lot #: p276230.Release to warehouse date: 21 jun 2017; 26 jul 2017; 22 sep 2017; 19 oct 2018 supplier: rti surgical.No ncr's 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.Visual inspection: the complaint device, cable tensioner with pistol grip (product code: 03.221.015 and lot number: p276230) was returned to customer quality (cq) west chester for investigation.Upon visual inspection no defects are found.Service and repair evaluation: the customer reported the cable tensioner with pistol grip was broken.The repair technician reported that the cable tensioner was disassembled, unable to test and also reported that the weld between the housing cap and the cam shaft has failed and disassembled.The cause of the issue could not be determined.The reason for repair is damaged component.The item could not be serviced/reworked and will be sent to customer quality.The evaluation was confirmed.Device failure/defect identified? yes.The weld breakage has been observed during the service evaluation.Dimensional inspection: a dimensional inspection was not performed as the internal components were inaccessible without destruction of the device.Document/specification review: based on the date of manufactured both the current and the manufactured revision drawings were reviewed: cable tensioner with trigger handle.Complaint confirmed? yes, the complaint can be confirmed based on the available information.Investigation conclusion: the complaint condition was confirmed for the device.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/ specification review.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 WITH PISTOL GRIP
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): RTI SURGICAL; 375 river park circle; marquette MI 49855
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12321492
• Report Number: 1833824-2021-00069
• Device Sequence Number: 14424961
• Product Code: LXH
• UDI-Device Identifier: 10886982076748
• UDI-Public: (01)10886982076748
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 07/16/2021

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: P276230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2017
• 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