MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA; REAMER

Model Number	314.742
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight not available for reporting.Additional product code: hrx.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a during a reamer/irrigator/aspirator (ria) bone graft harvest procedure on (b)(6) 2018 a ria drive shaft 360mm and a ria tube assembly 520mm broke in half.The ria bone graft harvest was the second stage of a planned augmentation of variable angle (va) condylar distal femur fixation.The first procedure required removal of antibiotic cement to fill bone void of a distal femur defect.The ria drive shaft 360mm and the ria tube assembly 520mm were assembled together and the surgeon began the femur reaming process.However, the ria would not advance past the femoral isthmus.The surgeon removed the ria assembly from the femur, suspecting that the ria reamer head was too large.When the surgeon removed the assembly from the femur it was discovered that the ria drive shaft 360mm and the ria tube assembly 520mm were broken in half.A small metal fragment fell off the tip of the drive shaft, but was easily removed.The devices were taken to a back table where it was discovered that the wrong drive shaft was connected to the tube assembly (short drive shaft 360mm + long tube assembly 520mm).The surgery was completed without incident using a new ria assembly.There was a reported 5 minute delay in surgery.Concomitant device reported: 14.5mm reamer head (352.255s, lot number unknown, quantity 1).This report is for one (1) drive shaft 360mm for ria.This is report 1 of 2 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.H3, h4, h6: device history records review was completed for part# 314.742, lot# 7004945.Supplier: (b)(4), release to warehouse date: nov 26, 2012.No non- conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.H3, h6: product development investigation was completed.As per the technique guide, during use the drive shaft is attached to the corresponding length reamer/irrigator/aspirator (ria) tube assembly and a reamer head and then connected to a drive unit.The ria system is intended for use to clear the medullary canal, to size the medullary canal, to harvest bone and bone marrow, and to remove infected and necrotic bone.The drive shaft was received with a portion of the distal tip, which mates with the reamer head, broken off.The broken portion was not received.The break is located distal to the helix.The helix is intact and shows minimal wear.The complaint condition is confirmed and consistent with the reported condition.Replication of the complaint condition is not applicable as the device is already broken.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.The lot went through the required steps during the inspection at the time of manufacturing and the dhr records showed no issues concerning the material.Hardness was not reviewed as the flexible nitinol shaft does not have a hardness specification.Based on the date of manufacture the relevant drawings, reflecting the current and manufactured revision, were reviewed.The outer diameter of the shaft was measured to be 5.181mm which is within the specification of 5.18mm +/- 0.025.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The complaint condition is the result of force applied to the distal end of the drive shaft resulting in stresses beyond the failure limit of the shaft.The root cause could not be definitively determined as the circumstances at the time of the break are unknown.The reamer/irrigator/aspirator (ria) technique guide addresses recommended use.It states that a cannulated drive unit that delivers only 3.5-4.5nm of torque and 700-900rpm is to be used.The technique guide also cautions that no reduction drive units or drills with a torque greater than 6nm should be used.It describes the recommend use for reaming as follows; ¿begin reaming, using a gradual advance/retract technique.Slowly advance 20-30mm and then retract 50-80mm allowing the irrigation fluid to flow in front of the reamer head.Advance the assembly until resistance is felt, then repeat.¿ no new malfunctions were observed during the course of this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: DRIVE SHAFT-MINIMUM 360MM LENGTH-FOR USE WITH RIA
• Common Device Name: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7397767
• Report Number: 2939274-2018-51450
• Device Sequence Number: 113880
• Product Code: HTO
• UDI-Device Identifier: 10886982189035
• UDI-Public: (01)10886982189035(10)7004945
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K042899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2018

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: 314.742
• Device Catalogue Number: 314.742
• Device Lot Number: 7004945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2018
• Initial Date Received by Manufacturer: 03/12/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 05/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR