MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 9.0MM MEDULLARY REAMER HEAD

Catalog Number 352.090

Device Problems Dull, Blunt (2407); Cut In Material (2454); Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient information is unknown.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.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 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 and there is no specific case information.The reamers are used daily for procedures not involving trauma cases.(b)(4).

• Brand Name: 9.0MM MEDULLARY REAMER HEAD
• Type of Device: REAMER
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA ; 6107195000
• MDR Report Key: 7186642
• MDR Text Key: 97497846
• Report Number: 2939274-2018-50223
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982194183
• UDI-Public: (01)10886982194183(10)LOTNUMBERUNKNOWN
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352.090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1