MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STARDRIVE SCREWDRIVER T25; SCREWDRIVERS

Catalog Number	314.118
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement associated with the complained event.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is synthes sales consultant.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(6) 2018, the t25 stardrive screwdriver was noticed to be loose and the shaft portion disconnected or broke off from the handle.The issue was identified at the back table when the surgical technician was preparing for the case while the operating room (or) team was positioning the patient.The procedure was a simple implant removal of a couple screws.The procedure was completed uneventfully without any delay.The issue did not impact the procedure or the patient.There was no patient involvement reported.This report is for one (1) stardrive screwdriver t25.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.A review of the device history records has been requested.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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device evaluated by mfr: part: 314.118; synthes lot: 4905140; supplier lot: na; release to warehouse date: december 10, 2004; manufactured by synthes brandywine.The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.No nonconformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Flow: broken visual inspection: the stardrive screwdriver was received at us cq with minimal signs of wear.The screwdriver shaft and the handle were still together but easily pulled apart.The screwdriver shaft connection to the handle was loose.This agrees with the reported complaint condition; thus, the complaint is confirmed.Dimensional inspection: dimensional analysis was completed, the outer diameter of the screwdriver shaft measured 6.99 mm.This is within specification of 6.97 mm to 7 mm, based on drawing.Document/specification review: the following drawing(s) was reviewed; t25 stardrive¿ screwdriver self-retaining 290 mm; screwdriver shaft self-retaining/ t25 stardrive¿.The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Conclusion: the complaint condition is confirmed as the stardrive screwdriver was received with the shaft and the handle connection loose and easy to come apart.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces (such as being dropped, struck off axis or damaged during sterile processing).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.

• Brand Name: STARDRIVE SCREWDRIVER T25
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7929703
• Report Number: 2939274-2018-54111
• Device Sequence Number: 1797571
• Product Code: HXX
• UDI-Device Identifier: 10886982188557
• UDI-Public: (01)10886982188557
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/10/2018

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: 314.118
• Device Lot Number: 4905140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 10/11/2018; 10/11/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 10/26/2018; 10/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1