MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED 2.5MM HEXAGONAL SCREWDRIVER

Model Number	314.29
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 the 314.29 handle broke during surgery.The issue was observed during surgery.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed and there was no further information regarding the issue.This complaint is for one (1) cannulated 2.5mm hexagonal screwdriver.This report is 1 of 1 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.H3, h4, h6: device history lot: product code: 314.29; lot number: 180417-101; part/lot combination are unknown at synthes gmbh, no dhr review possible.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and 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.D4: lot number provided for reporting.D9: complainant part is not expected to be returned for manufacturer review/investigation.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 2.5MM HEXAGONAL SCREWDRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11348089
• Report Number: 2939274-2021-00927
• Device Sequence Number: 17351324
• Product Code: HXX
• UDI-Device Identifier: 10886982188762
• UDI-Public: (01)10886982188762
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2021

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: 314.29
• Device Catalogue Number: 314.29
• Device Lot Number: 180417-101
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 03/18/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CANNULATED 2.5MM HEXAGONAL SCREWDRIVER.; CANNULATED 2.5MM HEXAGONAL SCREWDRIVER.