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

Catalog Number 03.168.007

Device Problem Unintended Movement (3026)

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 october 3, 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 two (2) devices.This report is for (1) nut for reamer component of the 03.168.004 this is report 2 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 03.168.007, lot f-24733: manufacturing site: selzach.Supplier: (b)(4).Release to warehouse date: october 29, 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: upon visual inspection, it was observed that internal threads were severely stripped and deformed.Several scratches and deformations were observed on the nut outer surface, which was consistent with damage resulted most likely while disassembling nut from the reamer.Thus the deformed complaint condition was confirmed.The functional test was performed for the received devices.The ø12.5mm reamer (mating device) was unable to be assembled with the nut component as internal threads in the nut component were severely stripped and deformed.Thus, the device interaction issue can be confirmed for the returned device.The dimensional inspection cannot be performed due to the post-manufacturing damage.The relevant drawings reflecting the current and manufactured revisions were reviewed.The complaint condition was confirmed for the received device as the device internal threads were stripped and deformed.It appears that the nut outer surface damage occurred while disassembling the cranked nut from the reamer device with an instrument like pliers.The alleged functional and device interaction issues may be caused due to the identified thread damage.No definitive root cause could be determined based on the provided information.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: NUT FOR 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: 10759034
• MDR Text Key: 213891360
• Report Number: 2939274-2020-04896
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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 Catalogue Number: 03.168.007
• Device Lot Number: F-24733
• 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: 11/04/2020
• Supplement Dates FDA Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 10.2MM CANNULATED DRILL BIT LENGTH 251MM; 12.5MM REAMER COMPONENT OF THE 03.168.004; 10.2MM CANNULATED DRILL BIT LENGTH 251MM