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

Model Number	391.201
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that on an unknown date, the patient underwent an unknown surgical procedure for an unknown reason.The cable tensioner was reported as broken during the procedure.No other information is known.It was unknown how the procedure was completed.It was unknown if there was surgical delay.Patient's outcome was unknown.This report is for one (1) cable tensioner.This is report 1 of 1 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: updated data: d4, h4.Investigation summary: visual inspection: the complaint device cable tensioner (product code: 391.201, lot number: p034022) was returned to cq west chester for investigation.During visual inspection, no issues were identified on the device.This device was investigated by rti surgical and this investigation was completed based on the report ¿signed report summary¿ functional test: during functional test, the device was tensioned to 50kg mark and the load cell reading was observed to be 40.6kg.This is within the specified range of 36-44kg.Can the complaint be replicated with the returned device(s)? the complaint condition was not replicated during functional test.Dimensional inspection: no issue warranting a dimensional inspection was identified.Document/specification review: based on the date of manufacture, the current and manufactured to version of drawing were reviewed.Complaint confirmed: no, the complaint condition cannot be confirmed during physical device investigation.Conclusion: the device functioned as intended during investigation, hence the complaint cannot be confirmed.A definitive assignable root cause could not be determined from the available information.There was no indication that a design or manufacturing issue contributed to the complaint.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 product code #: 391.201, synthes lot #: p034022 , supplier lot #: p034022, released to warehouse: 25aug2008, supplier: pioneer surgical technology.No ncrs were generated during production.Device history review: 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.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): RTI SURGICAL; 375 river park circle; marquette MI 49855
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12969725
• Report Number: 1833824-2021-00092
• Device Sequence Number: 11868092
• Product Code: LXH
• UDI-Device Identifier: 10886982198204
• UDI-Public: (01)10886982198204
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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
• Report Date (Section B): 11/11/2021

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: 391.201
• Device Catalogue Number: 391.201
• Device Lot Number: P034022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 12/10/2021
• Initial Report FDA Received Date: 12/09/2021
• Supplement Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2008
• 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