MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 13.0MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR

Model Number	352.252S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Patient id# (b)(6).Patient weight not provided for reporting.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device history records review was conducted.The report indicates that the: part # 352.252s, synthes lot # 7710277, supplier lot # na, expiration date: 31-may-2023, release to warehouse date: 06-aug-2014, manufactured by (b)(4).No ncr's were generated during production.Device history 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.Investigation summary: 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.
Event or Problem Description
It was reported, while the surgeon was using the reamer irrigator aspirator (ria), three (3) ria heads and the shaft of the drive broke.On (b)(6) 2018 a patient, implanted with a competitor¿s device, was undergoing a revision surgery due to a nonunion of a proximal humerus fracture.While the surgeon was harvesting bone graft from the femur, three (3) ria heads broke- 15mm, 13mm, and 12mm.It was also reported the shaft of the driver broke.The surgery was delayed for approximately twenty (20) minutes.No fragments were generated and nothing fell into the patient when the breakage occurred.Products will not be returning.Patient status was reported as stable.No additional information to report.This complaint involved four (4) devices only.This report is 2 of 4 for (b)(4).

• Brand Name: 13.0MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR
• Common Device Name: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7535934
• Report Number: 2939274-2018-52268
• Device Sequence Number: 16598954
• Product Code: HTO
• UDI-Device Identifier: 10886982194466
• UDI-Public: (01)10886982194466
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2018

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 Expiration Date: 05/31/2023
• Device Model Number: 352.252S
• Device Catalogue Number: 352.252S
• Device Lot Number: 7710277
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR