MAUDE Adverse Event Report: RTI SURGICAL PROVISIONAL TENSIONING DEVICE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	391.884
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent the surgery with the cable tensioner.First, the knob of the cable tensioner did not turn when the tension was being put on.After cutting the cable and washing the cable tensioner with physiological saline, the knob could be turned.Next, using a new cable, the tension was applied to the cable tensioner.Then locked the tension holder and the tension was released by reverse-rotating the knob, but the cable tensioner could not be removed from the tension holder.The surgery was completed successfully within thirty (30) minutes delay.No further information is available.This report is for one (1) provisional tensioning device.This is report 2 of 3 for complaint (b)(4).
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.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.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.The dimensional inspection was not performed due to the design of the device and inaccessibility of the internal components without the destruction of the device.The functional test was performed on this device per wi-eng-006, and it was found that the device held 36.4 kg which is considered an acceptable result.The device also passed the fray test per the same wi.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 tension holder f/temp-use as the device functioned as intended.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 history lot = > part # 391.884 lot # p351773 manufacturing site: selzach release to warehouse date: 29 oct2019 supplier: (b)(4) a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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: PROVISIONAL TENSIONING DEVICE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): RTI SURGICAL; 375 river park circle; marquette MI 49855
• Manufacturer Contact: dan nelson ; 375 river park circle; marquette, MI 49855
• MDR Report Key: 12983211
• Report Number: 1833824-2021-00094
• Device Sequence Number: 5352335
• Product Code: LXH
• UDI-Device Identifier: 07611819719859
• UDI-Public: (01)07611819719859
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2021

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 Catalogue Number: 391.884
• Device Lot Number: P351773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2021
• Supplement Date Received by Manufacturer: 02/07/2022; 02/09/2022
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 02/07/2022; 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2019
• 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: ATTACHM-BIT F/TENSION HOLDER; CABLE TENSIONER
• Patient Sex: Unknown