MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CURVED PELVIC OSTEOTOME 15MM WIDTH

Model Number	03.100.038
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.Part number: 03.100.038.Lot number: t145379.Manufacturing site: (b)(4).Release to warehouse date: 20-dec-2016.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed, and the used material was according to the specification of the device.Visual inspection: curved pelvic osteotome 15mm width (part.No: 03.100.038, lot.No: t145379, qty: 1) was returned and received at us cq.Upon visual inspection at customer quality (cq), it is observed that the edge of the distal end of the device was slightly deformed.No rusting was observed on the surface of the device.Document/ specification review: the following drawings were reviewed during the investigation: curved pelvic osteotome 15mm and 20mm blade.No design issues or discrepancies were noted during the investigation.Dimensional inspection: dimensional inspection of the device was not performed due to post manufacturing, and device design.Complaint confirmed? no rusting was observed on the surface of the device.Investigation conclusion: the complaint could not be confirmed for curved pelvic osteotome 15mm width (part.No: 03.100.038, lot.No: t145379).A definitive root cause for the reported problem could not be determined.It is possible that the sharp edge might have encountered unintended forces.During the investigation no unidentified product design/manufacturing issues, or discrepancies were observed that may have contributed to the complaint condition.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.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 curved pelvic osteotome 15mm and 20mm width were pitting on the edge of the blade during the inspection.There was no patient involvement.This report is for one (1) curved pelvic osteotome 15mm width.This is report 1 of 2 for (b)(4).

• Brand Name: CURVED PELVIC OSTEOTOME 15MM WIDTH
• Common Device Name: OSTEOTOME
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10727877
• Report Number: 2939274-2020-04806
• Device Sequence Number: 17174658
• Product Code: HWM
• UDI-Device Identifier: 10886982070876
• UDI-Public: 10886982070876
• Combination Product (Y/N): N
• 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): 10/20/2020

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: 03.100.038
• Device Catalogue Number: 03.100.038
• Device Lot Number: T145379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 10/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1