MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 28MM; PLATE, FIXATION, BONE

Model Number	204.828
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, on or about (b)(6) 2019 the patient had open reduction ulnar fracture proximal end with internal fixation of his right elbow.On or about (b)(6) 2020 patient was admitted and had an incision, drainage, and treatment for infection from his surgical site.On or about (b)(6) 2021, the patient's infected hardware was removed from his body.This report is for one (1) 3.5mm cortex screw self-tapping 28mm.This is report 4 of 10 for complaint.Product complaint (b)(4).
Additional Manufacturer Narrative
Additional product code: jds, hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: reporter is an attorney.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.
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.Investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the images.The images were reviewed, and the complaint condition is not confirmed.There are no visual defects on the device in the provided x-rays that would contribute to the complaint condition.A definitive assignable root cause could not be determined based on the provided information.No dhr review was completed since no lot number was supplied via photo or additional information.The dhr will be revisited when the physical device is received.As the device was not returned, an as-received condition could not be assessed and a dimensional inspection and specification review were not completed.During the investigation, no product design issues or discrepancies were observed (based on the image) 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.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: 3.5MM CORTEX SCREW SELF-TAPPING 28MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12860337
• Report Number: 2939274-2021-06780
• Device Sequence Number: 17231204
• Product Code: HRS
• UDI-Device Identifier: 10886982146328
• UDI-Public: (01)10886982146328
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2021

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: 204.828
• Device Catalogue Number: 204.828
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.7 METAPHYSEA SCR SLF-TPNG T8 SD REC/52; 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 16; 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 20; 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 22; 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 24; 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 26; 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 26; 3.5 LCKNG SCREW SLF-TPNG W/SD(TM) REC 22; UNK - PLATES: LCP DISTAL ULNA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male