MAUDE Adverse Event Report: SYNTHES GMBH TI LCP® ONE-THIRD TUBULAR PLATE W/COLLAR 5 HOLES/57MM; PLATE, FIXATION, BONE

Catalog Number 441.351S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/19/2023

Event Type  malfunction  

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.H10 additional narrative: 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.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 Description

Device report from japan reports an event as follows: it was reported that on (b)(6) 2023, the patient underwent a orif for distal medial tibia & distal anterolateral tibia.Adt plate was used on distal anterolateral tibia, and 1/3 circle plate was used on distal medial tibia.During the surgery, a drill-guide/3.5mm with a screw (03.133.004) was not attached to the plate.Therefore, instead of locking screw, cortex one was inserted in the plate.The surgery was completed successfully within 30 minutes surgical delay.No further information is available.This report is for a ti lcp® one-third tubular plate w/collar 5 holes/57mm.This is report 5 of 5 for (b)(4).

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.H4,h6 a manufacturing record evaluation was performed for the finished device product code: 441.351s-15, lot no: 6140p82, it was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 09-jun-2023, manufacturing site:jabil grenchen, expiry date:01-jun-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.

• Brand Name: TI LCP® ONE-THIRD TUBULAR PLATE W/COLLAR 5 HOLES/57MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): JABIL GRENCHEN; solothurnstrasse 186; grenchen CO 2540 ; SZ 2540
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18518853
• MDR Text Key: 332935884
• Report Number: 8030965-2024-00899
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982221780
• UDI-Public: (01)10886982221780
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K011335
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

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
• Device Operator: Health Professional
• Device Catalogue Number: 441.351S
• Device Lot Number: 6140P82
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/25/2023
• Initial Date FDA Received: 01/16/2024
• Supplement Dates Manufacturer Received: 01/22/2024
• Supplement Dates FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: THREADED DRILL GUIDE 2.8 F/SCREW 3.5 F/V; THREADED DRILL GUIDE 2.8 F/SCREW 3.5 F/V; THREADED DRILL GUIDE 2.8 F/SCREW 3.5 F/V; THREADED DRILL GUIDE 2.8 F/SCREW 3.5 F/V