MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PERIOSTEAL ELEVATOR 3MM CURVED BLADE-STRAIGHT EDGE

Catalog Number	399.48
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary background: it was reported that on an unknown date, during a routine incoming inspection of a loaner set, the periosteal elevator 3 mm curved blade-straight edge was observed broken.There was no known hospital or patient involvement.This complaint involves one (1) device.Investigation flow: damage.Visual inspection: the periosteal elevator 3 mm curved blade-straight edge (p/n 399.48 lot unk) was received with a portion of the phenolic handle broken off.The fracture is at the proximal end of the handle and the fragment was not returned.No other issues were identified with the returned components of the device.Device failure/defect identified? yes: the device failure/defect of broken handle was identified during the investigation and is related to the reported complaint condition.Dimensional inspection: dimensional inspection was not conducted due to post manufacturing damage of the handle and missing fragment.Document/specification review: a dhr review could not be performed as the lot number is not etched on the device.The following drawings were reviewed, since the exact date of manufacture is unknown.Periosteal elevators, 3 mm width 399_48 rev a to k.The device was manufactured prior to 399_48 rev c, as rev c (dco 0702079) changed the instrument design to include the lot number etching.This part was manufactured prior to 23jul02 and is over 17 years old.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Conclusion: the complaint condition is confirmed for the periosteal elevator 3 mm curved blade-straight edge (p/n 399.48 lot unk) as a portion of the phenolic handle was broken off.The fracture is at the proximal end of the handle and the fragment was not returned.While no definitive root cause could be determined, it is possible that the device encountered unintended forces and/or consistent use/reprocessing over the part¿s lifetime (17+ years) contributed to the complaint condition.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.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 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, during a routine incoming inspection of a loaner set, the periosteal elevator 3 mm curved blade-straight edge was observed broken.There was no known hospital or patient involvement.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: PERIOSTEAL ELEVATOR 3MM CURVED BLADE-STRAIGHT 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: 8885941
• Report Number: 2939274-2019-59729
• Device Sequence Number: 11374539
• Product Code: HTE
• UDI-Device Identifier: 10886982202833
• UDI-Public: (01)10886982202833
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/17/2019

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 Catalogue Number: 399.48
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 08/12/2019
• Patient Sequence Number: 1