MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM CORTEX SCREW SELF-TAPPING 22MM; SCREW, FIXATION, BONE

Model Number	204.822
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
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.Additional device product codes: jds, hrs.Implant date is an unknown day in 2016.Complainant part is not expected to be returned for manufacturer review/investigation.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 the patient underwent surgery to implant the devices in 2016.The patient found out that there was a problem with the implants approximately 2 months ago when he went to the er because his arm was bad, and x-rays were taken.The patient underwent revision surgery to remove the hardware.No further information is available.This report involves one 3.5mm cortex screw self-tapping 22mm.This is report 2 of 8 for (b)(4).

• Brand Name: 3.5MM CORTEX SCREW SELF-TAPPING 22MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16113689
• Report Number: 8030965-2023-00257
• Device Sequence Number: 20250755
• Product Code: HWC
• UDI-Device Identifier: 10886982146298
• UDI-Public: 10886982146298
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 204.822
• Device Catalogue Number: 204.822
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 01/06/2023
• 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 VA LCKNG SCR SLF-TPNG T8 SD REC 10; 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 30; 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 40; 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 50; 2.7/3.5 VA-LCP OLECRANON PL 2H/LT/90; 2.7MM CORTEX SCREW SELF-TAPPING 26MM; 3.5MM CORTEX SCREW SELF-TAPPING 26MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male