MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11.0MM REAMER HEAD FOR RIA 2 STERILE

Model Number	03.404.018S
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2021, using reamer irrigator aspirator (ria) ii for femur fracture, a 1mm reamer for 9mm nail was used.The surgeon was aggressively reaming with ria 2 even after being instructed on proper usage since the cortical bone was dense.A bend was placed distally near the end of the ball tip reaming rod.The surgeon still tried advancing the ria 2 but was not able to advance anymore.He then finished reaming.It was observed that if there is a bend in the reaming rod you cannot advance the reamer over the reaming rod.It was also determined that the reamer head broke because after the reamer head was retrieved there were remnants that showed up on the image in the distal femur.There was a five (5) minutes surgical delay.The patient and procedure outcome were unknown.This report involves one (1) 11.0mm reamer head for ria 2 sterile.This is report 5 of 6 for (b)(4).
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.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.

• Brand Name: 11.0MM REAMER HEAD FOR RIA 2 STERILE
• Common Device Name: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12782390
• Report Number: 2939274-2021-06583
• Device Sequence Number: 3885195
• Product Code: HTO
• UDI-Device Identifier: 10886982273963
• UDI-Public: (01)10886982273963
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K111437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.404.018S
• Device Catalogue Number: 03.404.018S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0573-2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DRIVE SHAFT FOR RIA 2 520MM; RIA 2 BONE HARVESTING KIT 520MM STERILE; RIA 2 BONE HARVESTING KIT 520MM STERILE; RIA 2 BONE HARVESTING KIT 520MM STERILE; RIA 2 BONE HARVESTING KIT 520MM STERILE; UNK - REAMING RODS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR
• Patient Sex: Male