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 Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2020
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.The instrument(s) was not returned and instead the investigation is done based on the supplied image(s).The image(s) was reviewed and the complaint condition could be confirmed as the reamer head can be seen with the broken fragments.As the instrument(s) was not returned an as received condition, dimensional inspection, material or drawing reviews are not applicable.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.A device history record (dhr) review was conducted: part # 03.404.019s, synthes lot # 58p1763, supplier lot # 58p1763, release to warehouse date: 15 jun 2020, expiration date: 30 apr 2030, supplier: (b)(4).No ncr's were generated during production 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 an unknown procedure on (b)(6) 2020, the surgeon was using reamer / irrigator / aspirator (ria) 2 on the left tibia.In the process of using ria, the 11.5mm reamer head came off the driveshaft and became stuck in the canal.The prongs off the 11.5mm reamer head broke off in the canal and were stuck in the tibial canal and had to be taken out.Fragments were generated.There was a surgical delay of thirty (30) minutes.The patient outcome is unknown.Concomitant device reported: unk - ria (part# unknown; lot# unknown; quantity: 1), unknown ria 2 drive shaft (part # unknown, lot # unknown, quantity 1).This report is for one (1) 11.5mm reamer head for ria 2 sterile.This is report 1 of 1 for complaint (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: 10817988
• Report Number: 2939274-2020-05072
• Device Sequence Number: 1114857
• Product Code: HTO
• UDI-Device Identifier: 10886982273970
• UDI-Public: (01)10886982273970
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 10/14/2020

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: 03.404.019S
• Device Catalogue Number: 03.404.019S
• Device Lot Number: 58P1763
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 11/10/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - DRIVE SHAFT; UNK - RIA