MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/18MM; SCREW, FIXATION, BONE

Model Number	02.231.218
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Malunion of Bone (4529)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2020 the patient had a fall and sustained a periprosthetic femur fracture requiring open reduction internal fixation (orif).The plate and screws were manufactured by synthes.Implants did not appear to be removed.On (b)(6) 2021 x-ray taken showed persistent displacement of a partially healed distal femur fracture with lateral plate and screw construct stable in position.On (b)(6) 2021 injection to left knee for pain performed.Pain has persisted despite physical therapy, bracing, and nerve blocks.On (b)(6) 2021: surgeon stated that the left knee is ligamentously loose to varus stress and pain on (b)(6) 2021 x-ray results stated that there is a periprosthetic fracture in the distal femoral diaphysis that is subacute to chronic.There is one shaft width posterior displacement of the distal fracture fragment.There is no evidence of hardware fracture or loosening.Surgeon states left knee is unstable likely secondary to malunion of the femur fracture with resultant shortening.On (b)(6) 2021: patient sustained two falls resulting in a pelvic and then a right humeral fracture.Medical records do not include the primary operative notes, nor the revision notes.This report is for one (1) 5.0mm variable angle locking screw/slf-tpng/strdrv/18mm this is report 7 of 12 for complaint (b)(4) this complaint (b)(4) is related to 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D2b: additional device product codes: jdp, hrs.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j attorney.H3, h4, h6: 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.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: 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/18MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 16747868
• Report Number: 8030965-2023-04680
• Device Sequence Number: 3264724
• Product Code: HWC
• UDI-Device Identifier: 10886982062017
• UDI-Public: (01)10886982062017
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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: 02.231.218
• Device Catalogue Number: 02.231.218
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 04/14/2023
• 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: 4.5 VA-LCP CRVD COND PL/16 HOLE/336/LFT; 5.0 VA LOCKNG SCR SLF-TPNG/SD/16; 5.0 VA LOCKNG SCR SLF-TPNG/SD/24; 5.0 VA LOCKNG SCR SLF-TPNG/SD/26; 5.0 VA LOCKNG SCR SLF-TPNG/SD/28; 5.0 VA LOCKNG SCR SLF-TPNG/SD/38; 5.0 VA LOCKNG SCR SLF-TPNG/SD/85; 5.0MM CANNULATED VA LOCKING SCREW/65MM; 5.0MM CANNULATED VA LOCKING SCREW/70MM; 5.0MM CANNULATED VA LOCKING SCREW/80MM; 5.0MM CANNULATED VA LOCKING SCREW/85MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female