MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM CORTEX SCREW SELF-TAPPING 16MM; SCREW, FIXATION, BONE

Model Number	204.816
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.H10 additional narrative: b1: adverse event or product problem: adverse event.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 mw5117888, a copy is attached.The only information contained in this report is correction or additional information.It was further reported that there were a total of three screws involved.The patient was reported to have been discharged on an unknown date.No further information was reported.(b)(4) is related to (b)(4), which reports an additional screw.This is report 1 of 3 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.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that 3.5mm cortex screw self-tapping 16mm was broken at the tip.The broken fragment was not returned.A dimensional inspection was not performed since it was not applicable to the complaint condition.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the 3.5mm cortex screw self-tapping 16mm would contribute to the complained device issue.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.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 16MM
• 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: 17169995
• Report Number: 8030965-2023-07737
• Device Sequence Number: 7038852
• Product Code: HWC
• UDI-Device Identifier: 10886982146267
• UDI-Public: (01)10886982146267
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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?: No
• Operator of Device: Health Professional
• Device Model Number: 204.816
• Device Catalogue Number: 204816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/23/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 3.5MM CORTEX SCREW SELF-TAPPING 16MM; 3.5MM CORTEX SCREW SELF-TAPPING 16MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown