MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC REAMING ROD PUSH ROD WITH BALL HANDLE; REAMER

Model Number	03.010.093
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on an unknown date, during inspection of the back up devices it was discovered that the gold peg of one (1) recon locking aiming arm for lfn nails-ex has snapped off, the threads of one (1) extraction screw for ti femoral & tibial nails and one (1) extraction screw/m8 for suprapatellar are stripped, and one (1) depth gauge for 2.0/2.4 and 2.7 screws was stuck in place.There was no patient involvement.Upon manufacturer investigation, the device was found to be discolored from the ball handle and deformed from the shaft.This report is for a reaming rod push rod with ball handle.This is report 6 of 6 for (b)(4).
Additional Manufacturer Narrative
Reporter is a synthes employee.A manufacturing related potential cause was not suspected, therefore, per franchise complaint product investigation procedure, no manufacturing record evaluation is required.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the reaming rod push rod with ball handle was found to be discolored from the ball handle and deformed from the shaft.Signs of rust were not visible.A dimensional inspection for the reaming rod push rod with ball handle was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the reaming rod push rod with ball handle would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.Drawing/specifications reviewed the following drawings reflecting the current and manufactured revisions were reviewed: reaming rod push rod with ball handle (current version).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: REAMING ROD PUSH ROD WITH BALL HANDLE
• Common Device Name: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14310804
• Report Number: 2939274-2022-01643
• Device Sequence Number: 12083936
• Product Code: HTO
• UDI-Device Identifier: 10886982067647
• UDI-Public: (01)10886982067647
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 03.010.093
• Device Catalogue Number: 03.010.093
• Device Lot Number: A7PA29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DEPTH GAUGE FOR 2.0/2.4 AND 2.7 SCREWS; DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; EXTRACTION SCR FOR TI FEM & TIB NAIL; EXTRACTION SCREW/M8 FOR SUPRAPATELLAR; RECON LCKNG AIMING ARM FOR LFN NAILS-EX; SMALL UNIVERSAL CHUCK WITH T-HANDLE; WIRE CUTTER 220MM
• Patient Sex: Unknown