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
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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: b3: unknown event date d9: complainant part is not expected to be returned for manufacturer review/investigation.E1: initial reporter is j&j company representative reporter telephone number: (b)(6).H4 device history product code: 214.838 lot no: 3576p74 manufacturing site: mezzovico release to warehouse date: 09 jan 23 a manufacturing record evaluation was performed for the not sterile finished lot number, and no non-conformance's were identified.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.
Event or Problem Description
Device report from synthese reports an event in columbia as follows: it was reported a revision surgery occurred on an unknown date in june 2023.The technical assistant performed the pre-operative plan with the surgeon, which was noted as "the plan is to remove the medial plate.The lateral plate will be left.Only the distal screws are to be released.The osteotomy will be performed, and the insert will be placed to correct the pseudoarthrosis".During the procedure the medial plate was removed and then the distal screws of the lateral plate were removed, but the plate was not removed.Osteotomy was performed and the insert was placed, then proceeded to fix the plate using new screws from j&j.It should be noted that 2 interfragmentary compression screws were also placed.The procedure ended without any novelty and with total normality.The plate implanted in the patient was from another brand, and the screws to fix this plate are from j&j.Original implant date was not noted.This is for one (1) 4.5mm cortex screw self-tapping 38mm for (b)(4).

• 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): MEZZOVICO; zona industriale 4; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17247897
• Report Number: 8030965-2023-08258
• Device Sequence Number: 6840666
• Product Code: HWC
• UDI-Device Identifier: 10886982154682
• UDI-Public: (01)10886982154682
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: 214.838
• Device Catalogue Number: 214.838
• Device Lot Number: 3576P74
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 07/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2023
• 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: Unknown