MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10.5MM REAMER HEAD FOR RIA 2 STERILE

Model Number	03.404.017S
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.This lot met all dimensional, visual, sterility, and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.
Event or Problem Description
Device report from synthes reports an event in the usa as follows: it was reported that on (b)(6) 2022, while using the ria 2, to harvest bone graft from a greater trochanteric start point the ria head broke off.The broken ria head was retrieved with the guide rod.Four metal fragments were retained in the right femur.We then dropped down a half a size to 10mm reamer head, followed by an 11mm reamer head and ,successfully reamed the femur and obtained the necessary bone graft.There were a surgical delay of 5 minutes.Procedure was completed successfully.Patient outcome was unknown.Concomitant device reported: unk - guides/sleeves/aiming: guide (part# unknown; lot# unknown; quantity: unknown).This complaint involves one(1) device 10.5mm reamer head for ria 2 sterile.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 10.5MM 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14786272
• Report Number: 2939274-2022-02325
• Device Sequence Number: 17351528
• Product Code: HTO
• UDI-Device Identifier: 10886982273949
• UDI-Public: (01)10886982273949
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: PRE-AMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2022

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: 03.404.017S
• Device Catalogue Number: 03.404.017S
• Device Lot Number: 342P114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2022
• Supplement Date Received by Manufacturer: 09/15/2022
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female