MAUDE Adverse Event Report: SYNTHES GMBH LOCKING SCREW FOR IM NAIL Ø 5MM/ 74MM/ XL25/ STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.045.074S
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2022
Type of Reportable Event	Malfunction
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: jds, hwc complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a synthes 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 device lot and no non-conformance was identified.Product code: 04.045.074s lot no: 433p673 manufacturing site: jabil grenchen release to warehouse date: 27/11/2021 expiry date: 01/10/2031.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 orif for distal femur fracture with the products in question.The patient had experienced a distal femur fracture in the past, so this time he or she was treated with conservative therapy.The bone quality was so poor that the screw head was buried in the cortex even with the washer + condylar nut.The surgery was completed without any surgical delay.No further information is available.This report is for a locking screw for im nail ø 5mm/ 74mm/ xl25/ sterile.This is report 1 of 1 for (b)(4).

• Brand Name: LOCKING SCREW FOR IM NAIL Ø 5MM/ 74MM/ XL25/ STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 16409118
• Report Number: 8030965-2023-02056
• Device Sequence Number: 5898264
• Product Code: HSB
• UDI-Device Identifier: 10886982294593
• UDI-Public: (01)10886982294593
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.045.074S
• Device Catalogue Number: 04.045.074S
• Device Lot Number: 433P673
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2021
• 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: LOCKSCR F/NAILS Ø5 L74 XL25; NUT Ø14; NUT Ø14; RETROGRADE FEM NAIL ADVANCED Ø12 L280 5°; RETROGRADE FEM NAIL ADVANCED Ø12 L280 5°; WASHER Ø17.5/11.8; WASHER Ø17.5/11.8
• Patient Sex: Unknown