MAUDE Adverse Event Report: RTI SURGICAL Ø1.7MM CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER; MISC ORTHO SURGICAL INSTR

Model Number	03.221.017
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 on (b)(6) 2019, during a retrograde intramedullary nailing of femur, as the unknown nail was implanted and the aiming arm was took off, the nail was noticed too buried.The surgeon was watching the knee while taking x rays and not the hip, he hit the nail down too far in this view.The surgeon tried to use the extraction bolt but the threads were too stripped to use.The nail was not explanted and was just backed up using another extractor device.There was no issue getting the insertion handle back on.Unknown cables were also used and went to insert a 1.7 cable through the gun but it would not pass.Something happened to the 1.7 cable lock and was jammed and broken.Backup devices were available.There was a 2 minute surgical delay.Procedure was successfully completed.Patient outcome was unknown.Concomitant device reported: unknown aiming arm (part # unknown, lot # unknown, quantity # 1), unknown insertion handle (part # unknown, lot # unknown, quantity # 1), unknown cable (part # unknown, lot # unknown, quantity # 1), unknown tensioning instrument (part # unknown, lot # unknown, quantity # 1).This is report 2 of 3 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.D10: part returned.H3, h4, h6: a review of the device history record.Device history lot; part number: 03.221.017; synthes lot number: p211920; supplier lot number: n/a; release to warehouse date: 19 jun 2015; expiration date: n/a; supplier: (b)(4).No ncrs were generated during production.Device history batch null, device history review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition h3, h6: investigation summary background: it was reported that on (b)(6) 2019, during a retrograde intramedullary nailing of femur, as the unknown nail was implanted and the aiming arm was took off, the nail was noticed too buried.The surgeon tried to use the extraction bolt but the threads were too stripped to use.There was no issue getting the insertion handle back on.Unknown cables were also used and went to insert a 1.7 cable through the gun but it would not pass.Something happened to the 1.7 cable lock and was jammed and broken.Backup devices were available.It is unknown if there was surgical delay, procedure was successfully completed.Patient outcome was unknown.Concomitant device reported: unknown nail (part # unknown, lot # unknown, quantity # 1), unknown aiming arm (part # unknown, lot # unknown, quantity # 1), unknown insertion handle (part # unknown, lot # unknown, quantity # 1), unknown cable (part # unknown, lot # unknown, quantity # 1), unknown tensioning instrument (part # unknown, lot # unknown, quantity # 1).This complaint involves two (2) devices.The investigation was performed at rti surgical.Flow: device interaction/functional.Visual and functional inspection: initial quality assurance inspections found the lever of the rear attachment to be stiff.Once the device was lubricated, it functioned as intended.Dimensional inspection: as the issue was determined to be related to the tensioner, dimensional inspection for this cable lock was not applicable.Once lubricated, the device was found to function as intended.Manufacturing record evaluation: a manufacturing record evaluation was conducted, there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Conclusion: the reported condition was partially confirmed for the device as it had difficulties in locking due to a lack of lubrication.Investigation results did not show the product broken, as lubrication solved the functional issues.A manufacturing root cause could not be established with the information obtained.This occurrence is below actionable limits.Further root cause analysis will not be performed at this time.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: Ø1.7MM 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: 8757791
• Report Number: 1833824-2019-00102
• Device Sequence Number: 16654119
• Product Code: LXH
• UDI-Device Identifier: 10886982076779
• UDI-Public: (01)10886982076779
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2019

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: P211920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - CABLE/WIRE; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM; UNK - NAIL INSERTION HANDLES; UNK - TENSIONING INSTRUMENTS
• Patient Age: 56 YR
• Patient Weight: 101