MAUDE Adverse Event Report: SYNTHES GMBH 5.0 LCKNG SCREW SLF-TPNG T25 SD REC 18; PLATE, FIXATION, BONE

Model Number	212.203
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6), 2022, the patient underwent hardware removal deep due to right femur painful hardware.The plate screws and stimulator bodies were removed.The stimulator electrodes were encased in bone and were not extracted.This report is for one (1) 5.0 lckng screw slf-tpng t25 sd rec 18.This is report 2 of 12 for complaint (b)(4).
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 product codes: hwc and ktt 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.

• Brand Name: 5.0 LCKNG SCREW SLF-TPNG T25 SD REC 18
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16709596
• Report Number: 8030965-2023-04393
• Device Sequence Number: 15290448
• Product Code: HRS
• UDI-Device Identifier: 10886982152107
• UDI-Public: (01)10886982152107
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K000682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• 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: 212.203
• Device Catalogue Number: 212.203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 04/10/2023
• 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: 13 TI CANN RETRO/ANTEGRADE FEM NL/420-S; 4.5 TI VA-LCP CRVD COND PL/12H/266/RT-S; 5.0 PERIPR VAL SCR/18 OPTILINK/SF-TPG/SD; 5.0 PERIPR VAL SCR/18 OPTILINK/SF-TPG/SD; 5.0 TI LCKNG SCR T25 SD 34 FOR IM NAILS; 5.0 TI LCKNG SCR T25 SD 66 FOR IM NAILS; 5.0 TI LCKNG SCR T25 SD 76 FOR IM NAILS; 5.0 TI LCKNG SCR T25 SD 76 FOR IM NAILS; 5.0 VAL SCREOPTILINK(TM) SLF-TPNG/SD/20; 5.0 VAL SCREOPTILINK(TM) SLF-TPNG/SD/22; 5.0 VAL SCREOPTILINK(TM) SLF-TPNG/SD/75; 5.0 VAL SCREOPTILINK(TM) SLF-TPNG/SD/80; 5.0 VAL SCREOPTILINK(TM) SLF-TPNG/SD/80
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female