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

Model Number	03.100.300
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a sales representative.A product investigation was conducted.Visual inspection: the device was received.The edges of distal tip of the device was found to be deformed/bent.The complaint can not be confirmed for pitting reported condition.Conclusion: after a visual inspection, it is determined that the device is worn from repeated use and servicing therefore, further investigation for the reported complaint device is not required.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 a device history record (dhr) review was conducted: part number: 03.100.300, lot number: t124299, manufacturing site: (b)(4), release to warehouse date: 06-jul-2015.A review of the device history records was performed for the finished device lot number and a nc was started because a monthly analysis of the bioburden level in the water at the final rinse showed the value for july 2015 to be out of specification.The analysis of products showed that no germs, bacteria or fungi were found on the product.For further investigation a corrective and preventative actions (capa) has been implemented.The necessary actions to ensure the final product quality have been taken and documented in the appropriate quality system.The nc have no impact to the complaint condition.The final quality release criteria were met before this batch was released for distribution.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 an inspection it was noticed that one (1) stardrive screwdriver's end was pitted, and one (1) straight pelvic osteotome's blade on the end was pitted.There was no patient involvement.During manufacturer's investigation of the returned devices it was observed that the edges of distal tip of the device was found to be deformed/bent.This device condition was reassessed and determined to be reportable on july 1, 2020.This report is for one (1) straight pelvic osteotome 15mm.This is report 1 of 2 for complaint (b)(4).

• Brand Name: STRAIGHT PELVIC OSTEOTOME 15MM
• Common Device Name: OSTEOTOME
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10254867
• Report Number: 2939274-2020-03186
• Device Sequence Number: 535918
• Product Code: HWM
• UDI-Device Identifier: 10886982071262
• UDI-Public: (01)10886982071262
• 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): 06/02/2020

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: 03.100.300
• Device Catalogue Number: 03.100.300
• Device Lot Number: T124299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1