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)
Date of Event	09/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used in a veterinary case ¿ no patient information will be reported.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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.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
Veterinary complaint: it was reported that during a procedure on (b)(6) 2019, the periosteal elevator straight blade snapped in two, almost in the midline, at the handle.The procedure was completed successfully with a five (5) minute delay.Patient was fine.This report is for a periosteal elevator.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
The periosteal elevator 14 mm straight blade-round edge (part # 399.37, lot # a7na40, mfg # week 40, 2004) was received at us (b)(4) with the handle broken transversely into 2 separate pieces.This is consistent with the reported complaint condition, thus confirming the complaint.The metallic portion of the instrument showed no signs of breakage.Dimensional analysis was not performed due to post manufacturing damage.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot: part number: 399.37, lot number: a7na40, manufacturing site: (b)(4).Release to warehouse date: week 40, 2004.A review of the device history records is not possible, the dhr is no longer available due to the age of the instrument (over 15 years old).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.

• 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: 9191798
• Report Number: 2939274-2019-61545
• Device Sequence Number: 14367543
• Product Code: HTE
• UDI-Device Identifier: 10886982202758
• UDI-Public: (01)10886982202758
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Initial Date Received by Manufacturer: 09/20/2019
• Supplement Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 11/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1