MAUDE Adverse Event Report: SYNTHES GMBH LOCKING SCREW FOR IM NAIL Ø 5MM/ 80MM/ XL25/ STERILE; SCREW, FIXATION, BONE

Catalog Number	04.045.080S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/24/2023
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: d2: additional procodes: jds, hsb.D9: complainant part is not expected to be returned for manufacturer review/investigation.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.A manufacturing record evaluation was performed for the finished device, product code: 04.045.080s, lot number: 3808p64, it was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 25/01/2023, manufacturing site: jabil grenchen, expiry date: 01/01/2033.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) 2023, the patient underwent an orif surgery for a fracture of the distal shaft of the femur.4 locking screws were inserted into the distal holes, 2 locking screws were inserted into the proximal holes, and the surgery was completed successfully with no surgical delay.On (b)(6) 2023, the patient complained pain on the lateral of the distal femur and the x-rays were taken.The x-rays showed that the screw inserted in the most distal hole backed out by approximately 15 mm.The surgeon made plans to remove the screw that backed out on (b)(6) 2023.No further information is available.This report is for a locking screw for im nail ø 5mm/ 80mm/ xl25/ sterile.This is report 1 of 1 for (b)(4).

• Brand Name: LOCKING SCREW FOR IM NAIL Ø 5MM/ 80MM/ XL25/ STERILE
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): JABIL GRENCHEN; solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18129832
• Report Number: 8030965-2023-14271
• Device Sequence Number: 6403211
• Product Code: HWC
• UDI-Device Identifier: 10886982294623
• UDI-Public: (01)10886982294623
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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 Catalogue Number: 04.045.080S
• Device Lot Number: 3808P64
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2023
• 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: RETROGRADE FEM NAIL ADVANCED Ø10 L300 5°
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female