MAUDE Adverse Event Report: RTI SURGICAL 1.7MM CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER; MISC ORTHO SURGICAL INSTR

Model Number	03.221.017
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
Product complaint # :(b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j sales representative.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 (b)(6) 2021, during an inspection, it was discovered that a cable lock for pistol will not lock directly.There was no patient involvement, this complaint involves one (1) device.This report is for (1) unk ¿ plates.This report is 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.H10 additional narrative: d7a; d9; g1; h4.H3, h6: the subject device has been received, the investigation is in progress, 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
This report is for a ø1.7mm cable lock for pistol grip cable tensioner.
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: 03.221.017.Synthes lot: p119635.Supplier lot: p119635.Release to warehouse date: april 20, 2012 supplier: pioneer surgical technology no nonconformance reports (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.Note: the complaint device was assessed and investigated by rti surgical (pioneer surgical), the manufacturer of the device.Visual inspection: the 1.7 cable lck pist grip cbl tensioner was received and evaluated at rti surgical.Visual inspection found the camming surface to be damaged with galling, damage to the rear of the bit and etch to be rusty.Functional test: functional inspection passed per the production routing requirement of holding tension without slipping while tensioning to the 50kg mark on the tensioner.Dimensional inspection: dimensional inspection was not performed due to post manufacturing damages present on the device.Document/specification review: source control drawings were reviewed.Manufacturer also performed a device history record (dhr) review and found that the device met manufacturing specifications prior to shipping.Investigation conclusion: the complaint condition cannot be confirmed for the 1.7 cable lck pist grip cbl tensioner as the device passed the functional test and the reported complaint condition could not be replicated.A root cause could not definitively be determined for the reported complaint condition from the available information.No new, unique, or different patient harms were identified as a result of this evaluation.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 preventive 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: 1.7MM CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): RTI SURGICAL; 375 river park circle; marquette MI 49855
• MDR Report Key: 12112182
• Report Number: 1833824-2021-00062
• Device Sequence Number: 11775334
• Product Code: LXH
• UDI-Device Identifier: 10886982076779
• UDI-Public: (01)10886982076779
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/10/2021

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: 03.221.017
• Device Catalogue Number: 03.221.017
• Device Lot Number: P119635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 07/13/2021; 08/31/2021; 09/03/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 08/09/2021; 08/31/2021; 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1