MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STARDRIVE SCREWDRIVER T25/SELF-RETAINING

Model Number	03.010.107
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.The device has been 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 that on an unknown date, the sterile processing department found the stardrive screwdriver self-retaining handle was broken.There was no patient involvement.This report involves one (1) stardrive screwdriver t25/self-retaining.This is report 1 of 1 for (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: h3, h4, h6: part 03.010.107, lot 5520254: release to warehouse date: june 01, 2007.Manufactured by synthes brandywine.No non-conformance reports (ncr's) 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.H3, h6: a product investigation was completed: upon visual inspection, it was observed that the distal tip was stripped/worn as the hex lobes were near worn to the core.The observed condition was consistent as an end of life indicator for the device.This was consistent with the reported complaint condition, thus confirming the complaint.The complaint was confirmed during the investigation.After a visual inspection, it is determined that the reusable instrument device is worn from repeated use and servicing.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventative action is not required.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.

• Brand Name: STARDRIVE SCREWDRIVER T25/SELF-RETAINING
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11077581
• Report Number: 2939274-2020-05718
• Device Sequence Number: 2974425
• Product Code: HXX
• UDI-Device Identifier: 10886982067791
• UDI-Public: (01)10886982067791
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/01/2020

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: 03.010.107
• Device Catalogue Number: 03.010.107
• Device Lot Number: 5520254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 12/28/2020; 01/15/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 12/29/2020; 01/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1