MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PELVIC OSTEOTOME 15MM/304MM

Model Number	399.85
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is a synthes employee part: 399.850, lot: t123705: manufacturing site: (b)(4).Release to warehouse date: september 25, 2015.A review of the device history records was performed for the finished device lot number, and no non-conformance's were identified.A product investigation was completed: the device was received with the cutting surface of the chisel dull.There is blunting of the cutting edge due to multiple uses.The distal tip of the device shows signs of wear.This is consistent with the reported complaint condition, thus confirming the complaint.After a visual inspection, it is determined that the chisel is worn from repeated use and servicing.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.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 on august 02, 2019, one (1) curved pelvic osteotomy chisel, one (1) pelvic osteotomy chisels, one (1) angled pelvic osteotomes and one (1) bayonet-shaped pelvic osteotomes were noticed to have gouges and flattening of the cutting edges through inspection.There was no patient and procedure involvement.This report is for a pelvic osteotomy chisel.This is report 2 of 4 for (b)(4).

• Brand Name: PELVIC OSTEOTOME 15MM/304MM
• Common Device Name: OSTEOTOME
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8951695
• Report Number: 2939274-2019-60258
• Device Sequence Number: 2859947
• Product Code: HWM
• UDI-Device Identifier: 10886982203113
• UDI-Public: (01)10886982203113
• 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): 08/02/2019

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: 399.85
• Device Catalogue Number: 399.850
• Device Lot Number: T123705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1