MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM CORTEX SCREW SELF-TAPPING 38MM; SCREW, FIXATION, BONE

Model Number	214.838
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2023, there was a hardware removal/revision surgery due to femoral nonunion.From the lateral side, the surgeon removed a va condylar plate and corresponding screws.From the medial side, the surgeon removed a va proximal tibia plate and corresponding screws.The surgeon then addressed the nonunion site, and placed 2 new plates onto the patient's femur.Three broken screws from the primary surgery were retained in patient's femur.This report is for one (1) 4.5mm cortex screw self-tapping 38mm.This is report 3 of 14 for complaint (b)(4).Additional devices are reported under related 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.H10 additional narrative: d2b: additional device product codes: ktt.D9: complainant part is not expected to be returned for manufacturer review/investigation.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.
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.Photo investigation: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device device.Visual analysis of the photo revealed that 4.5mm cortex screw self-tapping 38mm was broken and embedded to the femur.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Based on the information provided, potential cause may be attributable to unintended use of a tibial plate '3.5 va prox tib pl lrg bend/12h/207/lft' on the femur.Femoral plates allow for thicker screws that provide further support to weight loads.The overall complaint was confirmed for 4.5mm cortex screw self-tapping 38mm.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: 4.5MM CORTEX SCREW SELF-TAPPING 38MM
• 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 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 16896970
• Report Number: 8030965-2023-05953
• Device Sequence Number: 20368478
• Product Code: HWC
• UDI-Device Identifier: 10886982154682
• UDI-Public: (01)10886982154682
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K161616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 214.838
• Device Catalogue Number: 214.838
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 05/26/2023
• 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: 3.5 VA LCKNG SCR SLF-TPNG/SD/75; 3.5 VA LCKNG SCR SLF-TPNG/SD/75; 3.5 VA LCKNG SCR SLF-TPNG/SD/75; 3.5 VA LCKNG SCR SLF-TPNG/SD/75; 3.5 VA LCKNG SCR SLF-TPNG/SD/75; 3.5 VA PROX TIB PL LRG BEND/12H/207/LFT; 3.5MM CORTEX SCREW SELF-TAPPING 38MM; 3.5MM CORTEX SCREW SELF-TAPPING 38MM; 4.5 VA-LCP CRVD COND PL/16 HOLE/336/LFT; 5.0 VA LOCKNG SCR SLF-TPNG/SD/42; 5.0 VA LOCKNG SCR SLF-TPNG/SD/42; 5.0 VA LOCKNG SCR SLF-TPNG/SD/42; 5.0MM CANNULATED VA LOCKING SCREW/75MM; 5.0MM CANNULATED VA LOCKING SCREW/75MM; 5.0MM CANNULATED VA LOCKING SCREW/75MM; 5.0MM CANNULATED VA LOCKING SCREW/75MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female