MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCREWDRIVER HANDLE WITH HEX COUPLING-SMALL; SCREWDRIVERS

Model Number	311.005
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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) 2020, the screwdriver handle with hexagonal coupling for bone fixation system is not locking.There was no patient involvement.This report is for one (1) screwdriver handle with hex coupling-small.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d4; d10; h3, h4, h6: part number: 311.005; lot number: t958735; per jde, manufactured date: 04/01/2011.A manufacturing-related potential cause was not suspected, therefore, per franchise complaint product investigation procedure no manufacturing record evaluation is required.Visual inspection: the screwdriver handle with hex coupling small (p/n: 311.005, lot #: t958735) was returned and received by us customer quality (cq).Upon visual inspection, no defects were observed with the returned components of the device.Functional test: the functional test was not performed as the device was returned by itself.Can the complaint be replicated with the returned devices? unable to perform.Dimensional inspection: a dimensional inspection was not performed as the internal components were inaccessible without destruction of the device.Document/specification review: based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed driver assembly.Complaint confirmed? no.Investigation conclusion the complaint condition was unconfirmed for the screwdriver handle with hex coupling small (p/n: 311.005, lot #: t958735).There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.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.
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.H11: corrected data: g4: awareness date reported on follow up 1 report as january 07, 2020 but should have been february 17, 2020.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: SCREWDRIVER HANDLE WITH HEX COUPLING-SMALL
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9634857
• Report Number: 2939274-2020-00435
• Device Sequence Number: 19466583
• Product Code: HXX
• UDI-Device Identifier: 10887587035574
• UDI-Public: (01)10887587035574
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/07/2020

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: 311.005
• Device Catalogue Number: 311.005
• Device Lot Number: T958735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 01/07/2020; 03/03/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 02/28/2020; 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1