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	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on an unknown date, during a procedure, the handle of the elevator was chipped at the hilt.It was unknown if there was a patient involvement.This report is for one (1) periosteal elevator 14mm straight blade-round edge.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Additional narrative: reporter is a j&j sales representative.A product investigation was conducted.Visual inspection: the complaint device periosteal elvtr 14 str bld-round edge (product code: 399.37, lot number: a7ka25) was returned to cq west chester for investigation.The handle on the returned item was broken and cracked.The tip of the item had chipped and the shaft was discolored.These are wears associated with the usage of the device.The device was found to be in use for more than 20 years and these defects are end of life indicators for the item.According to company document, further investigation of the item is not needed.Conclusion: the elevator blade had worn out due to continuous usage for more than 20 years.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.A device history record (dhr) review was conducted: part number: 399.37.Lot number: a7ka25.Manufacturing site: (b)(4).Release to warehouse date: week 25, 2001.A review of the device history records is not possible, the dhr is no longer available due to the age of the instrument (over 20 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
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13416832
• Report Number: 2939274-2022-00315
• Device Sequence Number: 4685087
• Product Code: HTE
• UDI-Device Identifier: 10886982202758
• UDI-Public: (01)10886982202758
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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
• Device Lot Number: A7KA25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2022
• Initial Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown