MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12.5MM REAMER COMPONENT OF THE 03.168.004; INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH

Model Number 03.168.006

Device Problem Failure to Cut (2587)

Patient Problem No Patient Involvement (2645)

Event Date 10/03/2020

Event Type  malfunction  

Manufacturer Narrative

The device was 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 Description

It was reported that during a femoral neck system case on (b)(6) 2020, while surgeon was attempting to use the opening drill, he noticed something was not right as the opening drill wouldn¿t advance and not spinning.The drill is used to create a path for the plate in bolt in the neck and head of the femur.The problem was with the 12.5mm reamer and nit for the reamer threading together over the drill.After looking at it, it was noticed that the nut was loose.Attempted to tighten the nut, but it was not working.The surgeon ended up cranking in on it to make it tight.After the case, the scrub tech was trying to unscrew the nut, but it was stuck.The reported devices were able to be separated with the use of gloves and pliers.The threads of the nut looked mangled, as if they were cross threaded at one point.The procedure was successfully completed with 5 minutes surgical delay.There was no patient consequence reported.Concomitant device reported: 10.2mm cannulated drill bit (part # 03.168.005, lot # unknown, quantity 1).This complaint involves 2 devices.This report is for (1) 12.5mm reamer component of the 03.168.004.This is report 1 of 2 for (b)(4).

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: part 03.168.006, lot f-24838: manufacturing site: selzach.Supplier: (b)(4).Release to warehouse date: september 10, 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: a product investigation was completed: visual inspection, ø3.0 mm ø2.0 mm pins head surface was deformed.No other damages were observed on the device.The functional test was performed for the received devices.The ø12.5mm reamer was unable to be assembled with the nut component (mating device; 03.168.007) as internal threads in the nut component were severely stripped and deformed.Therefore, the alleged functional and device interaction issues cannot be confirmed for the complaint device as they were occurred due to the mating device damage.Deformation was observed on the ø3.0 mm ø2.0 mm pin components during functional testing and it appears that the deformation occurred while attempting to disassemble nut and reamer components.The dimensional inspection of the complaint device was not required as the alleged complaint condition was occurred due to the mating device damage.Furthermore, the dimensional inspection of the pin components cannot be performed due to the post-manufacturing damage.The relevant drawing was reviewed.The complaint condition was not confirmed for the received device as the alleged functional/device interaction issues were occurred due to the damaged mating device.Deformation was observed on the ø3.0 mm ø2.0 mm pin components and it appears that the deformation occurred while attempting to disassemble nut and reamer components.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 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: 12.5MM REAMER COMPONENT OF THE 03.168.004
• Type of Device: INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10759129
• MDR Text Key: 213867764
• Report Number: 2939274-2020-04895
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 10886982275004
• UDI-Public: (01)10886982275004
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/03/2020

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
• Device Operator: Health Professional
• Device Model Number: 03.168.006
• Device Catalogue Number: 03.168.006
• Device Lot Number: F-24838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Initial Date Manufacturer Received: 10/03/2020
• Initial Date FDA Received: 10/29/2020
• Supplement Dates Manufacturer Received: 10/30/2020
• Supplement Dates FDA Received: 11/20/2020
• Patient Sequence Number: 1
• Treatment: 10.2MM CANNULATED DRILL BIT LENGTH 251MM; NUT FOR REAMER COMPONENT OF THE 03.168.004; 10.2MM CANNULATED DRILL BIT LENGTH 251MM