MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED STARDRIVE SCREWDRIVER T40/SELF-RETAINING; SCREWDRIVERS

Model Number	03.010.110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 (b)(6) 2019, a piece of the wooden handle of the cannulated star drive screwdriver chipped off during cleaning in the sterile processing department.There was no patient involvement.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese 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: h3, h6: a product investigation was conducted.Visual inspection: the cannulated stardrive screwdriver t40/self-retaining (p/n 03.010.110 lot 5442041) was received showing a portion of the handle broken off towards the distal end.The broken off fragment(s) were not returned.No other visual issues were identified with the returned components of the device.The device failure/defect of broken handle was identified during the investigation and is related to the reported complaint condition.Dimensional inspection: dimensional inspection of the handle was not conducted due to post manufacturing damage and missing fragment(s).Document/specification review: the relevant drawings, reflecting the manufactured and current revision, were reviewed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Conclusion: the complaint condition is confirmed for the cannulated stardrive screwdriver t40/self-retaining (p/n 03.010.110 lot 5442041) as a portion of the handle was broken off towards the distal end.No definitive root cause could be determined.It is likely that the age and consistent device use and repeated reprocessing of the phenolic handle material has led to this confirmed complaint condition.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.H3, h4, h6: a device history record (dhr) review was conducted: p/n 03.010.110 lot 5442041 manufactured by synthese brandywine released to warehouse date: (b)(6) 2007 no ncrs were generated during production.Manufacturing record evaluation showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.H11 corrected data: g1: corrected physical manufacturer.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: CANNULATED STARDRIVE SCREWDRIVER T40/SELF-RETAINING
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8885025
• Report Number: 2939274-2019-59715
• Device Sequence Number: 14052538
• Product Code: HXX
• UDI-Device Identifier: 10886982067821
• UDI-Public: (01)10886982067821
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2019

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: 03.010.110
• Device Catalogue Number: 03.010.110
• Device Lot Number: 5442041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 09/14/2019
• Patient Sequence Number: 1