MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 0.25MM SLOTTED SCREWDRIVER BLD HEX COUPLING

Model Number	03.505.210
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.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) 2021, the extraction screw, hand reamer, and screwdriver did not work as intended.There were no patient consequences.This report is for (1) 0.25mm slotted screwdriver bld hex coupling.This is report 3 of 3 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Customer quality investigation: the device was not returned.A photo-investigation was performed on the images.Upon inspecting the images provided, the complaint condition could not be confirmed as no issues were observed with the device.Document/specification review: since the exact manufactured date of the device was not identified, the current revision of drawings was reviewed.No design issues or discrepancies were identified.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection was not completed.A manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.Conclusion: the complaint condition could not be confirmed during photo investigation.During the investigation, no product design issues, or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot: a manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.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: 0.25MM SLOTTED SCREWDRIVER BLD HEX COUPLING
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12564234
• Report Number: 2939274-2021-05883
• Device Sequence Number: 19117682
• Product Code: HXX
• UDI-Device Identifier: 10887587013947
• UDI-Public: 10887587013947
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

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: 03.505.210
• Device Catalogue Number: 03.505.210
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXTRACTION SCREW/M8 FOR SUPRAPATELLAR; HAND-REAMER F/MEDULL-CANAL Ø6