MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 14.5MM REAMER HEAD FOR RIA 2 STERILE

Model Number	03.404.025S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2012
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product code: hrx.Complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was conducted: part number:03.404.025s, synthes lot number: 33p4184, supplier lot number: n/a, release to warehouse date: 11dec2019, expiration date: n/a, supplier: (b)(4).No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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
It was reported that on (b)(6) 2020, while reaming with a ria2 for bone graft, the reamer head for ria 2 tip broke while taking the reamer back out after the first pass.No undue torque nor angulation was applied since it was an intact femur.It is unknown if there was surgical delay.Patient and procedure outcome is unknown.This report is for one (1) 14.5mm reamer head for ria 2 sterile.This is report 1 of 1 for (b)(4).

• Brand Name: 14.5MM 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
• MDR Report Key: 10786893
• Report Number: 2939274-2020-04969
• Device Sequence Number: 11503126
• Product Code: HTO
• UDI-Device Identifier: 10886982274083
• UDI-Public: (01)10886982274083
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K111437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2020

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
• Operator of Device: Health Professional
• Device Model Number: 03.404.025S
• Device Catalogue Number: 03.404.025S
• Device Lot Number: 33P4184
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 11/04/2020
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Weight: 150