MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM CANCELLOUS BONE SCREW FULLY THREADED/18MM; PLATE,FIXATION,BONE

Model Number	206.018
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional procode: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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 during an unknown procedure, the hardware in question was removed due to infection.It is unknown when the hardware was originally implanted.The procedure was successfully completed without surgical delay.Patient outcome is unknown.There is no further information available.This report is for one (1) 4.0mm cancellous bone screw fully threaded/18mm.This is report 2 of 11 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.H10 additional narrative: h3, h6: the investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The 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.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: 4.0MM CANCELLOUS BONE SCREW FULLY THREADED/18MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12488625
• Report Number: 2939274-2021-05502
• Device Sequence Number: 4345839
• Product Code: HRS
• UDI-Device Identifier: 10886982147240
• UDI-Public: 10886982147240
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 206.018
• Device Catalogue Number: 206.018
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/22/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 09/17/2021
• Supplement Report FDA Received Date: 10/15/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.5 CRTX SCR LOW PROF HD STPING/HEX/70; 3.5MM CORTEX SCREW SELF-TAPPING 12MM; 3.5MM CORTEX SCREW SELF-TAPPING 14MM; 3.5MM CORTEX SCREW SELF-TAPPING 16MM; 3.5MM CORTEX SCREW SELF-TAPPING 60MM; 4.0 CANCELLOUS BONE SCREW FULLY THRD/16; 4.0 CANCELLOUS BONE SCREW FULLY THRD/16; LCP ONE-THIRD TUB PL COLLAR 10 H/117; WASHER 7.0MM; WASHER 7.0MM; 3.5 CRTX SCR LOW PROF HD STPING/HEX/70; 3.5MM CORTEX SCREW SELF-TAPPING 12MM; 3.5MM CORTEX SCREW SELF-TAPPING 14MM; 3.5MM CORTEX SCREW SELF-TAPPING 16MM; 3.5MM CORTEX SCREW SELF-TAPPING 60MM; 4.0 CANCELLOUS BONE SCREW FULLY THRD/16; 4.0 CANCELLOUS BONE SCREW FULLY THRD/16; LCP ONE-THIRD TUB PL COLLAR 10 H/117; WASHER 7.0MM; WASHER 7.0MM
• Outcome Attributed to Adverse Event: Required Intervention