MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM TI CORTEX SCREW SELF-TAPPING 20MM; SCREW, FIXATION, BONE

Model Number	404.820
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from japan reports an event as follows: it was reported that on (b)(6) 2022, the patient underwent the primary surgery with the cortex screws and the plate for the diaphyseal fracture of the humerus.The patient was allowed to move without restrictions from about six months after the surgery.The patient complained of pain.However, x-ray did not show abnormality.The physician found that the cortex screw was broken, and back-out of the plate was confirmed.It is unknown which of the two screws was broken.On (b)(6) 2022, a revision surgery was performed.The plate was replaced, and iliac was transplanted.According to the surgeon, the screw breakage might have been caused by unrestricted mobility.No further information is available.This report is for a 3.5mm ti cortex screw self-tapping 20mm.This is report 1 of 2 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.Additional narrative: common device name: additional procode: hrs.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.Part #: 404.820s, lot #: 526p171.Manufacturing site: (b)(4).Release to warehouse date: 01, december 2021.Expiry date: 01, november 2031.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.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 TI CORTEX SCREW SELF-TAPPING 20MM
• 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: 15933781
• Report Number: 8030965-2022-10759
• Device Sequence Number: 12403009
• Product Code: HWC
• UDI-Device Identifier: 10886982207326
• UDI-Public: (01)10886982207326
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131186
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 404.820
• Device Catalogue Number: 404.820S
• Device Lot Number: 526P171
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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: CORTSCR Ø3.5 SELF-TAP L22 TI; LCP PL 3.5 7HO L98 TI
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown