MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM/3.5MM TI LCP® METAPHYSEAL PLATE 13 HOLES; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 424.758S

Device Problem Break (1069)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Loss of Range of Motion (2032)

Event Type  Injury  

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.E1 initial reporter phone number: (b)(6).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 synthes reports an event in (b)(6) as follows: it was reported that on an unknown date the plate broke post-op.It was reported that the patient was accidentally pressed to the right lower limb by a heavy object and underwent surgery at the hospital 19 months ago.During the surgery, one plate and 9 screws were implanted, and the surgery was successful.10 months ago, after bone grafting, an additional plate and 7 screws were added.However, the patient developed right calf pain, calf deformity, and limited mobility due to no obvious cause the previous day.The outpatient x-ray examination showed that the right tibia and fibula fracture was found to have a broken plate.For further diagnosis and treatment, the outpatient department plans to admit the patient to the hospital for the treatment of "right lower leg fracture with steel plate fracture".After 6 days of surgery, the right lower limb tibial plate fracture, local tibial deformity, middle and lower tibial fracture with bone defect were observed during the surgery, and callus formation was observed during internal fixation with steel plates and screws.Two broken plates and 16 screws were removed to fully stop bleeding.The external fixation bracket was stable, and the c-arm fluoroscopy internal fixation device was completely removed during the surgery.After the surgery, the patient returned to the ward safely.This report involves one (1) 4.5mm/3.5mm ti lcp® metaphyseal plate 13 holes.This is report 2 of 2 for (b)(4).This product complaint is related to (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Product code: 424.758.Lot number: 9464012.Release to warehouse date: (b)(6) 2015.Expiration date: na.Supplier: na.Manufacturing site: (b)(6).The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from the photo.Visual analysis of the photo revealed that the lcp metaphyspl 3.5/4.5/5 broad 5+8ho l20 had broken across the most proximal locking screw hole #6.X-ray image shows two plate and screw constructs, one at the lateral (424.758s - lcp metaphyspl 3.5/4.5/5 broad 5+8ho l20) and the other at the medial aspect (423.621 - lcp 3.5 12ho l163 ti) of the right tibia along with fracture of the fibula, as the fragments do not meet each other, this could be an indicative of a possible resection osteotomy to make a fracture reduction of the tibia.The broken section presents slight signs of tissue around the bone, probably indicating non-union.The edges of the tibial fracture appear to be displaced laterally, possibly from early weight bearing and/or side loading.However, with the available information, a root cause cannot be established for the failure of the plate.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the lcp metaphyspl 3.5/4.5/5 broad 5+8ho l20.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.G1: manufacturing site name & address corrected.

• Brand Name: 4.5MM/3.5MM TI LCP® METAPHYSEAL PLATE 13 HOLES
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK GRENCHEN; solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17572521
• MDR Text Key: 321428263
• Report Number: 8030965-2023-10423
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K033805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 424.758S
• Device Lot Number: 9464012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LCP 3.5 12HO L163 TI; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male