MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11.5MM REAMER HEAD FOR RIA 2 STERILE

Model Number	03.404.019S
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot: part # 03.404.019s, synthes lot #: 46p3533, supplier lot # 46p3533, release to warehouse date: 27-feb-2020, expiration date: 28-feb-2030, supplier: (b)(4).Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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 during bone grafting on (b)(6) 2020, the 11.5mm and 10.5mm reamer/ irrigator/ aspirator (ria 2) reamer heads were sheared off in the canal and left inside the patient.The procedure was successfully completed without a surgical delay.Patient status is unknown.Concomitant device reported: unknown ria 2 drive shaft (part # unknown, lot # unknown, quantity unknown).This report is for one (1) 11.5mm reamer head for ria 2 sterile.This is report 1 of 2 for (b)(4).

• Brand Name: 11.5MM 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: 10397006
• Report Number: 2939274-2020-03507
• Device Sequence Number: 17026352
• Product Code: HTO
• UDI-Device Identifier: 10886982273970
• UDI-Public: (01)10886982273970
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: PRE-AMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2020

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: 03.404.019S
• Device Catalogue Number: 03.404.019S
• Device Lot Number: 46P3533
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 08/12/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10.5MM REAMER HEAD FOR RIA 2 STERILE; UNK - RIA 2 DRIVE SHAFT
• Outcome Attributed to Adverse Event: Required Intervention