MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STARDRIVE SCREWDRIVER SHAFT W/HOLDING SLEEVE/T4/66MM; SCREWDRIVERS

Model Number	03.114.009
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: reporter is a synthes employee.Part: 03.114.009 (60061590).Lot: 3493559.Manufacturing site: (b)(4).Release to warehouse date: october 29, 2010.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the instrument was inspected, and nothing is broken.Instead, the sd4 star drive blade is missing from the construct preventing it from functioning as intended.No other issues were observed.Document/specification review: the following drawing(s) was reviewed: t4 star drive blade with spring holding sleeve.Sd4 star drive blade.Holding sleeve.No design or manufacturing defect or deficiency was observed during the investigation.From the drawings, it can be seen that the blade is needed for the device to function as intended and therefore, a conclusive determination has been reached.A manufacturing record evaluation was performed, and no issues were noted.Conclusion: a definitive root cause for this complaint could not be determined.It is most likely that disassembly of the device for sterile processing and misplacing of the components contributed to this complaint.During the investigation, no product design or manufacturing issues 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.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 during a routine incoming inspection of a loaner's set on an unknown date, a star drive screwdriver shaft with holding sleeve was found broken.There was no patient involvement.This report is for a star drive screwdriver shaft with holding sleeve.This is report 1 of 1 for (b)(4).

• Brand Name: STARDRIVE SCREWDRIVER SHAFT W/HOLDING SLEEVE/T4/66MM
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9075763
• Report Number: 2939274-2019-60621
• Device Sequence Number: 2976745
• Product Code: HXX
• UDI-Device Identifier: 10886982073037
• UDI-Public: (01)10886982073037
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 08/19/2019

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: 03.114.009
• Device Catalogue Number: 03.114.009
• Device Lot Number: 3493559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1