MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM CORTEX SCREW SELF-TAPPING 14MM; SCREW, FIXATION, BONE

Model Number	204.814
Medical Device Problem Code	Break (1069)
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: a1-a5: patient information added.B1: adverse event or product problem: adverse event + malfunction.B2: outcome attributed to adverse event: required intervention to prevent permanent impairment/damage.D1: brand name updated.D2b: additional device product codes: jds, hrs.D3: manufacturer address updated.D4: udi added.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.D10: concomitant devices added.E1: initial reporter facility name added.E4: initial reporter sent report to fda: yes.G1: manufacturer contact information added.G2: is report source a health professional: yes.G4: 510k added.H1: type of event updated to serious injury.H5: labeled for single use: yes.H6: health effect impact codes, medical device problem code, health effect clinical code updated.H3, h4, h6: 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
This report is against user facility medwatch number mw5117887, a copy is attached.The only information contained in this report is correction or additional information.It was reported that the surgery was completed successfully and the patient was discharged home.This report involves one 3.5mm cortex screw self-tapping 14mm.This is report 1 of 1 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.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: 3.5MM CORTEX SCREW SELF-TAPPING 14MM
• 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: 17180784
• Report Number: 8030965-2023-07831
• Device Sequence Number: 20456919
• Product Code: HWC
• UDI-Device Identifier: 10886982146250
• UDI-Public: (01)10886982146250
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K131186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other
• 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 204.814
• Device Catalogue Number: 204814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 07/18/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 99 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White