MAUDE Adverse Event Report: SYNTHES MONUMENT 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/8 H/RT-STER; PLATE,FIXATION,BONE

Catalog Number 02.118.206S

Device Problem Break (1069)

Patient Problems Fall (1848); Failure of Implant (1924); Pain (1994); No Code Available (3191)

Event Date 03/23/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.(b)(6).(b)(4) revision surgery was required to remove and replace the broken plate.Device history records was conducted.The report indicates that the manufacturing location: (b)(4), manufacturing date: 30-jan-2015, expiration date: 01-31-2025, part #: 02.118.206s, lot#: 7883901 (sterile) - 2.7/3.5 mm va-lcp anterolateral distal tibia pl/8 h/rt-sterile.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Scn no: (b)(4).¿sterility documentation was reviewed and determined to be conforming.¿ the investigation could not be completed; no conclusion could be drawn, as no product was received.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 on an event in (b)(6) as follows: it was reported that there was an open fx of tibia and fibula: patient was treated with a va-ant.Lat.Dist tibia plate on tibia after reduction.Fibula was left untreated due to the fact of infection risk.Five days later the patient felt that she got more pain, went to the doctor next day.The plate was broken in the shaft.They have preform a secondary surgery removing the broken plate with new plate and this time they could also treat fibula with a plate and screw.Principle of treatment was absolutely stability with plate and screw.All the screw was undamaged.No trauma was involved and the patient was not allowed to take weight bearing just take the steps in the air.This complaint involves one part.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Subject device has been received and is currently in the evaluation process.(b)(4).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

Event clarification: a patient experienced a fracture of both their tibia and fibula, however only the tibia was treated due to risk of infection.The patient was implanted with a variable angle (va) distal tibia plate for fracture reduction.Five (5) days post-operatively the patient fell and experienced pain.The plate was confirmed as broken in the shaft.A revision surgery was performed and the broken plate was removed, along with the screws holding the plate.All of the explanted screws were undamaged.A new plate and screws were implanted to treat both the patient's tibia and fibula.

Manufacturer Narrative

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.

Manufacturer Narrative

A manufacturing evaluation was completed: the plate is broken at the threaded part of the fourth variable angle plate hole.The dimensions of the investigated va-lcp anterolateral distal tibial plate (as far as measurable) were checked using a digital sliding calliper and found to be in compliance with the technical drawing and specifications.Based on the topography of the fracture surface, we can conclude that the implant was subjected to dynamic bending loads (one sided).Constantly alternating bending (e.G.During walking) led to the fatigue of the material, then to a first crack and finally to the overload respectively to the fatigue fracture of the distal tibial plate.The implant could not resist the applied force which finally led to the material overload and fatigue failure.Postoperative activities of the patient may have played a certain role, too.A failure resulting from either a material or manufacturing defect can be excluded.Exact date of plate breakage is unknown.It was reported five days after implantation the patient started feeling pain and the next day the patient went to the doctor and it was discovered the plate was broken.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: 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/8 H/RT-STER
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5573628
• MDR Text Key: 42532612
• Report Number: 1719045-2016-10312
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.118.206S
• Device Lot Number: 7883901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 72