MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM CORTEX SCREW SELF-TAPPING 30MM; SCREW, FIXATION, BONE

Catalog Number	204.830
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Deformity/ Disfigurement (2360)
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from india reports an event as follows: on (b)(6) 2022 the patient met with a road traffic accident through bike and sustained injuries, head and pelvic fracture.The injuries are like head injury, diffuse traumatic subarachnoid hemorrhage, left orbital wall fracture and patella/left hip fracture.On (b)(6) 2022 the patient underwent (1st component) open reduction & internal fixation with tension bond wiring for left patella.(2nd component) orif recon plate for anterior column left acetabulum.(3rd component) orif with recon plate posterior column left acetabulum.On (b)(6) 2022 the distal femur pin applied due to the surgeon did not properly used the c-arm and ignore the component left patella which led to the implant got failed due to discrepancy reduction and using pins for temporary solution/treatment.On (b)(6) 2022 left frontal burr hole evacuation of subdural collection & placement of subdural reservoir.On (b)(6) 2022 the patient underwent (2nd component of 1st surgery) revision acetabulum with ao posterior plate.Anterior quadrilateral plate and ao buttress plate (re-do of 3rd item of the 1st surgery due to the fracture reduction got failed with a stiffness of left hip joint spine reformity.This report is for a 3.5mm cortex screw self-tapping 30mm.This is report 1 of 10 for (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.H10 additional narrative: d2: additional procode: jds.D9: complainant part is not expected to be returned for manufacturer review/investigation.D10: date of concomitant therapy is (b)(6) 2022.H3, h6: 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.A manufacturing record evaluation was performed for the finished device product code: 204.830, lot number: 719p261.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 15/03/2022, manufacturing site: jabil grenchen.Product was not returned.Based on the information available, it has been determined that no corrective and 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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 3.5MM CORTEX SCREW SELF-TAPPING 30MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): JABIL GRENCHEN; solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17863722
• Report Number: 8030965-2023-12489
• Device Sequence Number: 14934892
• Product Code: HWC
• UDI-Device Identifier: 10886982146335
• UDI-Public: (01)10886982146335
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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 Catalogue Number: 204.830
• Device Lot Number: 719P261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2022
• 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: CORTEX SCREW Ø 3.5 MM, SELF-TAPPING, LEN; CORTEX SCREW Ø 3.5 MM, SELF-TAPPING, LEN; CORTEX SCREW Ø 3.5 MM, SELF-TAPPING, LEN; CORTEX SCREW Ø 3.5 MM, SELF-TAPPING, LEN; CORTEX SCREW Ø 3.5 MM, SELF-TAPPING, LEN; CORTEX SCREW Ø 3.5 MM, SELF-TAPPING, LEN; CORTEX SCREW Ø 3.5 MM, SELF-TAPPING, LEN; RECOPL 3.5 CURV R88 12HO L156 SST; RECOPL 3.5 STRAIG 13HO L169 SST
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown