MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM TI CORTEX SCREW SELF-TAPPING 46MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	414.846
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/05/2022
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.Additional narrative: additional procodes: hwc, hrs.D9: complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.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.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part # 414.846s lot # 8l27310 manufacturing site: (b)(4).Release to warehouse date: 10 june 2021 expiration date: 01 june 2031 supplier: früh verpackungstechnik ag non-sterile part # 414.846 non-sterile lot # 188p039 manufacturing site: (b)(4).Release to warehouse date: 31 march 2021 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.
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 open reduction internal fixation surgery for fracture of femoral trochanter with 3 screws.On september 5, when the patient visited the hospital due to pain, it was confirmed that 3 screws were broken.The reoperation is not scheduled because the patient feels a little pain.If the reoperation is performed, the artificial bone head will be used.Excessive telescoping occurred because the bone fragment was intramedullary.When the blade contacted the barrel portion of the plate, telescoping was suppressed, and the implant could not tolerate the load of the varus of the bone fragment, which may have caused the screw to break.Distal plate portion bounces outward.The surgery was completed successfully without any surgical delay.No further information is available.This report is for a 4.5mm ti cortex screw self-tapping 46mm.This is report 3 of 3 for (b)(4).

• Brand Name: 4.5MM TI CORTEX SCREW SELF-TAPPING 46MM
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 15519788
• Report Number: 8030965-2022-07630
• Device Sequence Number: 12269284
• Product Code: KTT
• UDI-Device Identifier: 10886982213730
• UDI-Public: (01)10886982213730
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161616
• 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: 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 414.846
• Device Catalogue Number: 414.846S
• Device Lot Number: 8L27310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2022
• Initial Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2021
• 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: DHS BLADE Ø12.5 L85 TAN; LCP DHS-PL 135° 3HO L76 STANDBARREL TAN; LOCKSCR Ø5 SELF-TAP L46 TAN; LOCKSCR Ø5 SELF-TAP L46 TAN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male