MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PERIOSTEAL ELEVATOR 14MM STRAIGHT BLADE-ROUND EDGE

Model Number	399.37
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.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 on an unknown date, the periosteal elevator 14 mm straight blade-round edge was in need of repair.The blade has separated from the handle.The issue was discovered upon inspection in sterile processing department (spd).There was no patient involvement.This report is for one (1) periosteal elevator 14 mm straight blade-round edge.This is report 1 of 1 for (b)(4).

• Brand Name: PERIOSTEAL ELEVATOR 14MM STRAIGHT BLADE-ROUND EDGE
• Common Device Name: ELEVATOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9082456
• Report Number: 2939274-2019-60676
• Device Sequence Number: 11463550
• Product Code: HTE
• UDI-Device Identifier: 10886982202758
• UDI-Public: (01)10886982202758
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: PRE-AMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2019

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: 399.37
• Device Catalogue Number: 399.37
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1