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 Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no known reported patient involvement associated with the complained event.Date of event is unknown.Device is an instrument and is not implanted/explanted.Complainant device is not expected to be returned for manufacturer review/investigation.(b)(4).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.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 repeatedly for procedures not involving trauma cases.The hospital usually have at least eight (8) reamer sets in use and the most common sizes are 8.5mm thru 12.5mm.The hospital central sterile personnel investigates the reamers for tissue and debris before each procedure.This report is for nine (9) devices.(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; PA 19380
• MDR Report Key: 7188011
• Report Number: 2939274-2018-50246
• Device Sequence Number: 1903191
• Product Code: HTO
• UDI-Device Identifier: 10886982194251
• UDI-Public: (01)10886982194251(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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