MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 12.5MM MEDULLARY REAMER HEAD

Catalog Number	352.125
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: no patient involvement was reported.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 by the hospital that the reamer head cutting instruments are not sharp enough.Hospital feels that this is a major patient safety issue.The reamers are getting stuck and not completing the ream because they are too dull.The age of each of the devices is unknown.No specific case information.The reamers are used day in and day out for procedures not involving trauma cases.It is believed that the hospital has eight (8) reamer sets in use and the most common sizes used are 8.5mm thru 12.5mm.The hospital (b)(6) personnel investigates the reamers for tissue and debris before each procedure.This report is for one (1) 12.5mm medullary reamer head.(b)(4).

• Brand Name: 12.5MM MEDULLARY REAMER HEAD
• Common Device Name: REAMER
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7187761
• Report Number: 2939274-2018-50244
• Device Sequence Number: 11250701
• Product Code: HTO
• UDI-Device Identifier: 10886982194251
• UDI-Public: (01)10886982194251(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 12/13/2017

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 Catalogue Number: 352.125
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 01/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1